Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 6) 18GX6" FEMORAL ART LINE KIT, Pack Number ART960A; 7) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 8) BIOPSY TRAY, Pack Number BT1015; 9) BIOPSY TRAY, Pack Number BT1060; 10) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number BT1095; 11) BIOPSY KIT, Pack Number BT450A ; 12) CHEST TUBE INSERTION TRAY , Pack Number CHT1020; 13) CHEST TUBE INSERTION KIT, Pack Number CHT1465; 14) CHEST TUBE INSERTION TRAY , Pack Number CHT2040; 15) CHEST TUBE INSERTION TRAY , Pack Number CHT2040H ; 16) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 17) CHEST TUBE INSERTION TRAY , Pack Number CHT701 ; 18) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 19) CIRCUMCISION TRAY, Pack Number CIT6260; 20) CIRCUMCISION TRAY, Pack Number CIT6325; 21) CIRCUMCISION TRAY , Pack Number CIT6575A ; 22) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 23) CHEST TUBE INSERTION TRAY , Pack Number CVI2105; 24) CHEST TUBE INSERTION TRAY , Pack Number CVI2105H ; 25) EXTREMITY PACK, Pack Number CVI4680; 26) CVC INSERTION PACK, Pack Number CVI4720; 27) VENOUS ACCESS TRAY, Pack Number CVI4830A; 28) VENOUS ACCESS TRAY, Pack Number CVI4830B; 29) MVHS CVC LUMEN TRAY, Pack Number CVI4920; 30) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960A; 31) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 32) CATHETER ON/OFF KIT, Pack Number DT5490B; 33) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 34) BIOPSY KIT, Pack Number DYNDA1466A; 35) CUP KIT, Pack Number DYNDA1506; 36) DERMATOLOGY KIT, Pack Number DYNDA1567D; 37) TDC REMOVAL, Pack Number DYNDA1633A; 38) PAN MP TRACHEOSTOMY, Pack Number DYNDA1635; 39) PERM CATH, Pack Number DYNDA1732A; 40) CATH REMOVAL, Pack Number DYNDA1733B; 41) CATH REMOVAL, Pack Number DYNDA1814; 42) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 43) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 44) PORT TUNNEL CATH REMOVAL TRAY, Pack Number DYNDA2033A; 45) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 46) PULL D/C PACK, Pack Number DYNDA2080; 47) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 48) PAIN TRAY, Pack Number DYNDA2416; 49) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 50) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 51) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 52) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523A; 53) GENERAL UTILITY, Pack Number DYNDA2524; 54) SHUNT TRAY, Pack Number DYNDA2725; 55) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 56) PICU LINE TRAY, Pack Number DYNDC1960A; 57) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 58) PORT ACCESS KIT, Pack Number DYNDC2945; 59) PRE POST DIALYSIS, Pack Number DYNDC3274; 60) BMA BX TRAY, Pack Number DYNDH1050A; 61) BONE MARROW TRAY - NO NEEDLE, Pack Number DYNDH1059; 62) BIOPSY PACK SM, Pack Number DYNDH1093; 63) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 64) ARTHROGRAM TRAY, Pack Number DYNDH1113; 65) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 66) BIOPSY TRAY, Pack Number DYNDH1129; 67) ARTHROGRAM TRAY, Pack Number DYNDH1134; 68) BIOPSY PACK, Pack Number DYNDH1137A; 69) BIOPSY TRAY, Pack Number DYNDH1137C; 70) ARTHROGRAM PACK, Pack Number DYNDH1148; 71) ULTRASOUND TRAY, Pack Number DYNDH1204; 72) IR PICC TRAY, Pack Number DYNDH1223; 73) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 74) BIOPSY TRAY-LF, Pack Number DYNDH1229; 75) ARTHROGRAM TRAY, Pack Number DYNDH1243; 76) BIOPSY PACK, Pack Number DYNDH1248; 77) BONE MARROW BIOPSY TRAY, Pack Number DYNDH1251; 78) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 79) BIOPSY TRAY, Pack Number DYNDH1269; 80) BIOPSY TRAY, Pack Number DYNDH1273; 81) FLUORO PROCEDURE TRAY, Pack Number DYNDH1276; 82) BONE MARROW
FDA recall Z-3020-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 6) 18GX6" FEMORAL ART LINE KIT, Pack Number ART960A; 7) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 8) BIOPSY TRAY, Pack Number BT1015; 9) BIOPSY TRAY, Pack Number BT1060; 10) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number BT1095; 11) BIOPSY KIT, Pack Number BT450A ; 12) CHEST TUBE INSERTION TRAY , Pack Number CHT1020; 13) CHEST TUBE INSERTION KIT, Pack Number CHT1465; 14) CHEST TUBE INSERTION TRAY , Pack Number CHT2040; 15) CHEST TUBE INSERTION TRAY , Pack Number CHT2040H ; 16) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 17) CHEST TUBE INSERTION TRAY , Pack Number CHT701 ; 18) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 19) CIRCUMCISION TRAY, Pack Number CIT6260; 20) CIRCUMCISION TRAY, Pack Number CIT6325; 21) CIRCUMCISION TRAY , Pack Number CIT6575A ; 22) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 23) CHEST TUBE INSERTION TRAY , Pack Number CVI2105; 24) CHEST TUBE INSERTION TRAY , Pack Number CVI2105H ; 25) EXTREMITY PACK, Pack Number CVI4680; 26) CVC INSERTION PACK, Pack Number CVI4720; 27) VENOUS ACCESS TRAY, Pack Number CVI4830A; 28) VENOUS ACCESS TRAY, Pack Number CVI4830B; 29) MVHS CVC LUMEN TRAY, Pack Number CVI4920; 30) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960A; 31) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 32) CATHETER ON/OFF KIT, Pack Number DT5490B; 33) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 34) BIOPSY KIT, Pack Number DYNDA1466A; 35) CUP KIT, Pack Number DYNDA1506; 36) DERMATOLOGY KIT, Pack Number DYNDA1567D; 37) TDC REMOVAL, Pack Number DYNDA1633A; 38) PAN MP TRACHEOSTOMY, Pack Number DYNDA1635; 39) PERM CATH, Pack Number DYNDA1732A; 40) CATH REMOVAL, Pack Number DYNDA1733B; 41) CATH REMOVAL, Pack Number DYNDA1814; 42) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 43) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 44) PORT TUNNEL CATH REMOVAL TRAY, Pack Number DYNDA2033A; 45) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 46) PULL D/C PACK, Pack Number DYNDA2080; 47) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 48) PAIN TRAY, Pack Number DYNDA2416; 49) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 50) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 51) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 52) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523A; 53) GENERAL UTILITY, Pack Number DYNDA2524; 54) SHUNT TRAY, Pack Number DYNDA2725; 55) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 56) PICU LINE TRAY, Pack Number DYNDC1960A; 57) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 58) PORT ACCESS KIT, Pack Number DYNDC2945; 59) PRE POST DIALYSIS, Pack Number DYNDC3274; 60) BMA BX TRAY, Pack Number DYNDH1050A; 61) BONE MARROW TRAY - NO NEEDLE, Pack Number DYNDH1059; 62) BIOPSY PACK SM, Pack Number DYNDH1093; 63) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 64) ARTHROGRAM TRAY, Pack Number DYNDH1113; 65) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 66) BIOPSY TRAY, Pack Number DYNDH1129; 67) ARTHROGRAM TRAY, Pack Number DYNDH1134; 68) BIOPSY PACK, Pack Number DYNDH1137A; 69) BIOPSY TRAY, Pack Number DYNDH1137C; 70) ARTHROGRAM PACK, Pack Number DYNDH1148; 71) ULTRASOUND TRAY, Pack Number DYNDH1204; 72) IR PICC TRAY, Pack Number DYNDH1223; 73) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 74) BIOPSY TRAY-LF, Pack Number DYNDH1229; 75) ARTHROGRAM TRAY, Pack Number DYNDH1243; 76) BIOPSY PACK, Pack Number DYNDH1248; 77) BONE MARROW BIOPSY TRAY, Pack Number DYNDH1251; 78) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 79) BIOPSY TRAY, Pack Number DYNDH1269; 80) BIOPSY TRAY, Pack Number DYNDH1273; 81) FLUORO PROCEDURE TRAY, Pack Number DYNDH1276; 82) BONE MARROW (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
openFDA drug & device enforcement (recall) reports
FDA recall Z-3020-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 6) 18GX6" FEMORAL ART LINE KIT, Pack Number ART960A; 7) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 8) BIOPSY TRAY, Pack Number BT1015; 9) BIOPSY TRAY, Pack Number BT1060; 10) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number BT1095; 11) BIOPSY KIT, Pack Number BT450A ; 12) CHEST TUBE INSERTION TRAY , Pack Number CHT1020; 13) CHEST TUBE INSERTION KIT, Pack Number CHT1465; 14) CHEST TUBE INSERTION TRAY , Pack Number CHT2040; 15) CHEST TUBE INSERTION TRAY , Pack Number CHT2040H ; 16) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 17) CHEST TUBE INSERTION TRAY , Pack Number CHT701 ; 18) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 19) CIRCUMCISION TRAY, Pack Number CIT6260; 20) CIRCUMCISION TRAY, Pack Number CIT6325; 21) CIRCUMCISION TRAY , Pack Number CIT6575A ; 22) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 23) CHEST TUBE INSERTION TRAY , Pack Number CVI2105; 24) CHEST TUBE INSERTION TRAY , Pack Number CVI2105H ; 25) EXTREMITY PACK, Pack Number CVI4680; 26) CVC INSERTION PACK, Pack Number CVI4720; 27) VENOUS ACCESS TRAY, Pack Number CVI4830A; 28) VENOUS ACCESS TRAY, Pack Number CVI4830B; 29) MVHS CVC LUMEN TRAY, Pack Number CVI4920; 30) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960A; 31) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 32) CATHETER ON/OFF KIT, Pack Number DT5490B; 33) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 34) BIOPSY KIT, Pack Number DYNDA1466A; 35) CUP KIT, Pack Number DYNDA1506; 36) DERMATOLOGY KIT, Pack Number DYNDA1567D; 37) TDC REMOVAL, Pack Number DYNDA1633A; 38) PAN MP TRACHEOSTOMY, Pack Number DYNDA1635; 39) PERM CATH, Pack Number DYNDA1732A; 40) CATH REMOVAL, Pack Number DYNDA1733B; 41) CATH REMOVAL, Pack Number DYNDA1814; 42) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 43) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 44) PORT TUNNEL CATH REMOVAL TRAY, Pack Number DYNDA2033A; 45) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 46) PULL D/C PACK, Pack Number DYNDA2080; 47) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 48) PAIN TRAY, Pack Number DYNDA2416; 49) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 50) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 51) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 52) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523A; 53) GENERAL UTILITY, Pack Number DYNDA2524; 54) SHUNT TRAY, Pack Number DYNDA2725; 55) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 56) PICU LINE TRAY, Pack Number DYNDC1960A; 57) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 58) PORT ACCESS KIT, Pack Number DYNDC2945; 59) PRE POST DIALYSIS, Pack Number DYNDC3274; 60) BMA BX TRAY, Pack Number DYNDH1050A; 61) BONE MARROW TRAY - NO NEEDLE, Pack Number DYNDH1059; 62) BIOPSY PACK SM, Pack Number DYNDH1093; 63) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 64) ARTHROGRAM TRAY, Pack Number DYNDH1113; 65) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 66) BIOPSY TRAY, Pack Number DYNDH1129; 67) ARTHROGRAM TRAY, Pack Number DYNDH1134; 68) BIOPSY PACK, Pack Number DYNDH1137A; 69) BIOPSY TRAY, Pack Number DYNDH1137C; 70) ARTHROGRAM PACK, Pack Number DYNDH1148; 71) ULTRASOUND TRAY, Pack Number DYNDH1204; 72) IR PICC TRAY, Pack Number DYNDH1223; 73) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 74) BIOPSY TRAY-LF, Pack Number DYNDH1229; 75) ARTHROGRAM TRAY, Pack Number DYNDH1243; 76) BIOPSY PACK, Pack Number DYNDH1248; 77) BONE MARROW BIOPSY TRAY, Pack Number DYNDH1251; 78) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 79) BIOPSY TRAY, Pack Number DYNDH1269; 80) BIOPSY TRAY, Pack Number DYNDH1273; 81) FLUORO PROCEDURE TRAY, Pack Number DYNDH1276; 82) BONE MARROW
The FDA logged enforcement record Z-3020-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 6) 18GX6" FEMORAL ART LINE KIT, Pack Number ART960A; 7) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 8) BIOPSY TRAY, Pack Number BT1015; 9) BIOPSY TRAY, Pack Number BT1060; 10) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number BT1095; 11) BIOPSY KIT, Pack Number BT450A ; 12) CHEST TUBE INSERTION TRAY , Pack Number CHT1020; 13) CHEST TUBE INSERTION KIT, Pack Number CHT1465; 14) CHEST TUBE INSERTION TRAY , Pack Number CHT2040; 15) CHEST TUBE INSERTION TRAY , Pack Number CHT2040H ; 16) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 17) CHEST TUBE INSERTION TRAY , Pack Number CHT701 ; 18) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 19) CIRCUMCISION TRAY, Pack Number CIT6260; 20) CIRCUMCISION TRAY, Pack Number CIT6325; 21) CIRCUMCISION TRAY , Pack Number CIT6575A ; 22) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 23) CHEST TUBE INSERTION TRAY , Pack Number CVI2105; 24) CHEST TUBE INSERTION TRAY , Pack Number CVI2105H ; 25) EXTREMITY PACK, Pack Number CVI4680; 26) CVC INSERTION PACK, Pack Number CVI4720; 27) VENOUS ACCESS TRAY, Pack Number CVI4830A; 28) VENOUS ACCESS TRAY, Pack Number CVI4830B; 29) MVHS CVC LUMEN TRAY, Pack Number CVI4920; 30) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960A; 31) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 32) CATHETER ON/OFF KIT, Pack Number DT5490B; 33) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 34) BIOPSY KIT, Pack Number DYNDA1466A; 35) CUP KIT, Pack Number DYNDA1506; 36) DERMATOLOGY KIT, Pack Number DYNDA1567D; 37) TDC REMOVAL, Pack Number DYNDA1633A; 38) PAN MP TRACHEOSTOMY, Pack Number DYNDA1635; 39) PERM CATH, Pack Number DYNDA1732A; 40) CATH REMOVAL, Pack Number DYNDA1733B; 41) CATH REMOVAL, Pack Number DYNDA1814; 42) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 43) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 44) PORT TUNNEL CATH REMOVAL TRAY, Pack Number DYNDA2033A; 45) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 46) PULL D/C PACK, Pack Number DYNDA2080; 47) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 48) PAIN TRAY, Pack Number DYNDA2416; 49) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 50) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 51) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 52) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523A; 53) GENERAL UTILITY, Pack Number DYNDA2524; 54) SHUNT TRAY, Pack Number DYNDA2725; 55) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 56) PICU LINE TRAY, Pack Number DYNDC1960A; 57) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 58) PORT ACCESS KIT, Pack Number DYNDC2945; 59) PRE POST DIALYSIS, Pack Number DYNDC3274; 60) BMA BX TRAY, Pack Number DYNDH1050A; 61) BONE MARROW TRAY - NO NEEDLE, Pack Number DYNDH1059; 62) BIOPSY PACK SM, Pack Number DYNDH1093; 63) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 64) ARTHROGRAM TRAY, Pack Number DYNDH1113; 65) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 66) BIOPSY TRAY, Pack Number DYNDH1129; 67) ARTHROGRAM TRAY, Pack Number DYNDH1134; 68) BIOPSY PACK, Pack Number DYNDH1137A; 69) BIOPSY TRAY, Pack Number DYNDH1137C; 70) ARTHROGRAM PACK, Pack Number DYNDH1148; 71) ULTRASOUND TRAY, Pack Number DYNDH1204; 72) IR PICC TRAY, Pack Number DYNDH1223; 73) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 74) BIOPSY TRAY-LF, Pack Number DYNDH1229; 75) ARTHROGRAM TRAY, Pack Number DYNDH1243; 76) BIOPSY PACK, Pack Number DYNDH1248; 77) BONE MARROW BIOPSY TRAY, Pack Number DYNDH1251; 78) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 79) BIOPSY TRAY, Pack Number DYNDH1269; 80) BIOPSY TRAY, Pack Number DYNDH1273; 81) FLUORO PROCEDURE TRAY, Pack Number DYNDH1276; 82) BONE MARROW — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: 81239, Lot Number 24DDA646; 81239, Lot Number 24BDA159; 81239, Lot Number 24ADA118; 81239, Lot Number 23LDB385; 81239, Lot Number 23FDB922; 81239, Lot Number 23FDB435; 81239, Lot Number 23CDC570; 81239, Lot Number 23BDA790; 81239, Lot Number 23ADA161; 81239, Lot Number 22LDA211; 81239, Lot Number 22KDA441; 81239, Lot Number 22HDA985; 81239, Lot Number 22GDB017; 81239, Lot Number 22FDA642; 81239, Lot Number 22BDB971; 81239, Lot Number 22BDB067; 81239, Lot Number 22BDA725; 81239, Lot Number 21LDA117; 81239, Lot Number 21KDB172; 81239, Lot Number 21HDA966; 81239, Lot Number 21GDD227; 81239, Lot Number 21DDC268; 81239, Lot Number 21DDA425; 81239, Lot Number 21CDB386; 81239, Lot Number 21BDB285; 81239, Lot Number 21ADA073; 946279 , Lot Number 21BKA450 ; ART1165, Lot Number 2022081890; ART1165, Lot Number 2022111890; ART1165, Lot Number 2023071190; ART1165, Lot Number 2023083190; ART1165, Lot Number 2023092290; ART1165, Lot Number 2023110990; ART1165, Lot Number 2023122990; ART1165, Lot Number 2024031290; ART1210, Lot Number 2023080190; ART240B, Lot Number 2023112290; ART240B, Lot Number 2024031590; ART960A, Lot Number 2023082890; ART960A, Lot Number 2023092790; ART960A, Lot Number 2023112990; ART960A, Lot Number 2023122190; ART960A, Lot Number 2024020190; ART970A, Lot Number 2023082890; ART970A, Lot Number 2023120790; BT1015, Lot Number 2019031190; BT1015, Lot Number 2021030190; BT1015, Lot Number 2022030490; BT1060, Lot Number 2020010790; BT1060 , Lot Number 21HBS949 ; BT1060 , Lot Number 21IBP676 ; BT1060 , Lot Number 21KBR236 ; BT1060 , Lot Number 21LBF894 ; BT1060 , Lot Number 22ABX733 ; BT1060 , Lot Number 22FBK864 ; BT1060 , Lot Number 22KBP269 ; BT1060 , Lot Number 23EBD654 ; BT1060 , Lot Number 23FBP748 ; BT1060 , Lot Number 23KBC222 ; BT1060 , Lot Number 23LBL371 ; BT1060 , Lot Number 21ABF385 ; BT1060 , Lot Number 21ABT342 ; BT1060 , Lot Number 21BBO441 ; BT1060 , Lot Number 21CBV637 ; BT1095, Lot Number 2020020790; BT1095, Lot Number 2020022690; BT450A , Lot Number 21JBG947 ; CHT1020, Lot Number 21JBN310 ; CHT1465, Lot Number 21HBR240 ; CHT1465, Lot Number 21KBC516 ; CHT1465, Lot Number 22BBH387 ; CHT1465, Lot Number 22BBR031 ; CHT1465, Lot Number 22FBU118 ; CHT1465, Lot Number 21DBD915 ; CHT1465, Lot Number 22IMD540 ; CHT1465, Lot Number 23CMC009 ; CHT1465, Lot Number 23EMA144 ; CHT1465, Lot Number 23FMA800 ; CHT1465, Lot Number 23FME610 ; CHT1465, Lot Number 23FMF447 ; CHT1465, Lot Number 23HMB406 ; CHT1465, Lot Number 23HMD786 ; CHT1465, Lot Number 23IME835 ; CHT1465, Lot Number 23JMJ875 ; CHT1465, Lot Number 23KMI144 ; CHT2040, Lot Number 22HBM306 ; CHT2040, Lot Number 23HBC212 ; CHT2040, Lot Number 23HBS289 ; CHT2040, Lot Number 23IBE762 ; CHT2040H , Lot Number 22HBM306 ; CHT2040H , Lot Number 23HBC212 ; CHT2040H , Lot Number 23HBS289 ; CHT2040H , Lot Number 23IBE762 ; CHT560, Lot Number 2019073090; CHT560, Lot Number 2020080390; CHT701 , Lot Number 21FBO591 ; CHT701 , Lot Number 21JBW717 ; CHT701 , Lot Number 21VBA867 ; CHT701 , Lot Number 21KBN653 ; CHT701 , Lot Number 22CBO057 ; CHT701 , Lot Number 22EBG420 ; CHT701 , Lot Number 22JBM927 ; CHT701 , Lot Number 22JBT787 ; CHT701 , Lot Number 23GBR820 ; CHT701 , Lot Number 23JBK474 ; CHT701 , Lot Number 21CBO702 ; CHT701 , Lot Number 21FBD963 ; CHT705, Lot Number 2020012990; CIT6260, Lot Number 2021101590; CIT6325, Lot Number 2023120790; CIT6575A , Lot Number 22KBS245 ; CIT6575A , Lot Number 22LBL593 ; CIT6785A, Lot Number 2021072790; CIT6785A, Lot Number 2021111690; CIT6785A, Lot Number 2023102490; CVI2105, Lot Number 21JBM278 ; CVI2105, Lot Number 21KBS086 ; CVI2105, Lot Number 21BBH919 ; CVI2105, Lot Number 21CBI631 ; CVI2105, Lot Number 21CBI632 ; CVI2105, Lot Number 21DBA095 ; CVI2105, Lot Number 22FMD732 ; CVI2105, Lot Number 22HMD248 ; CVI2105, Lot Number 23EMI806 ; CVI2105, Lot Number 23FMA158 ; CVI2105, Lot Number 23FMH191 ; CVI2105, Lot Number 23HMD107 ; CVI2105, Lot Number 23JMD860 ; CVI2105, Lot Number 23KMF012 ; CVI2105, Lot Number 23LMC909 ; 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DYNDH1540A, Lot Number 2023072890; DYNDH1556A, Lot Number 2021071950; DYNDH1556B, Lot Number 2021122950; DYNDH1559, Lot Number 2020091850; DYNDH1570, Lot Number 2020092350; DYNDH1570, Lot Number 2021062250; DYNDH1570, Lot Number 2022042350; DYNDH1570, Lot Number 2022062890; DYNDH1570, Lot Number 2022082290; DYNDH1570, Lot Number 2023051290; DYNDH1570, Lot Number 2023071490; DYNDH1570, Lot Number 2023121390; DYNDH1574, Lot Number 2020102150; DYNDH1574, Lot Number 2021031250; DYNDH1574, Lot Number 2021061150; DYNDH1574, Lot Number 2021062850; DYNDH1574, Lot Number 2021081850; DYNDH1574, Lot Number 2021102850; DYNDH1574, Lot Number 2021121450; DYNDH1574, Lot Number 2022060150; DYNDH1580, Lot Number 2021050650; DYNDH1580, Lot Number 2021092050; DYNDH1580, Lot Number 2022041150; DYNDH1585, Lot Number 2021011150; DYNDH1585, Lot Number 2021042750; DYNDH1585, Lot Number 2021061050; DYNDH1585, Lot Number 2022070250; DYNDH1585, Lot Number 2022071450; DYNDH1588, Lot Number 2021060450; DYNDH1588, Lot Number 2021071950; 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DYNDH1727, Lot Number 2022071750; DYNDH1755, Lot Number 2022072750; DYNDH1841, Lot Number 2023031590; DYNDH1841A, Lot Number 2023092190; DYNDH1841A, Lot Number 2023112190; DYNDL1096, Lot Number 2019032990; DYNDL1096, Lot Number 2019052090; DYNDL1096, Lot Number 2019062690; DYNDL1096, Lot Number 2019081390; DYNDL1096, Lot Number 2019120990; DYNDL1096, Lot Number 2020020790; DYNDL1159B, Lot Number 2019011480; DYNDL1159B, Lot Number 2019041580; DYNDL1159B, Lot Number 2019052080; DYNDL1159B, Lot Number 2019081280; DYNDL1159B, Lot Number 2019091680; DYNDL1159B, Lot Number 2020040680; DYNDL1187A, Lot Number 2018061390; DYNDL1187A, Lot Number 2018072090; DYNDL1187A, Lot Number 2018081390; DYNDL1187A, Lot Number 2019011890; DYNDL1187A, Lot Number 2019083090; DYNDL1250C, Lot Number 2018082490; DYNDL1250C, Lot Number 2019051690; DYNDL1250C, Lot Number 2019061490; DYNDL1250C, Lot Number 2019090490; DYNDL1250C, Lot Number 2019093090; DYNDL1250C, Lot Number 2020022190; DYNDL1422A, Lot Number 2019072690; DYNDL1422A, Lot Number 2019111990; DYNDL1422A, Lot Number 2019120990; DYNDL1422A, Lot Number 2020022090; DYNDL1422A, Lot Number 2020031790; DYNDL1443B, Lot Number 2018050950; DYNDL1461, Lot Number 2018082950; DYNDL1461, Lot Number 2018092050; DYNDL1461, Lot Number 2018111550; DYNDL1461, Lot Number 2019020750; DYNDL1461, Lot Number 2019040150; DYNDL1461, Lot Number 2019051750; DYNDL1461, Lot Number 2019070250; DYNDL1461, Lot Number 2019071950; DYNDL1461, Lot Number 2019091850; DYNDL1461, Lot Number 2019101150; DYNDL1461, Lot Number 2019111250; DYNDL1461, Lot Number 2019121250; DYNDL1461, Lot Number 2020071650; DYNDL1461, Lot Number 2020081350; DYNDL1461, Lot Number 2020092150; DYNDL1461, Lot Number 2020102650; DYNDL1461, Lot Number 2021051750; DYNDL1461, Lot Number 2021071450; DYNDL1461, Lot Number 2021102750; DYNDL1461, Lot Number 2022013150; DYNDL1462B, Lot Number 2018031950; DYNDL1462B, Lot Number 2018032150; DYNDL1462B, Lot Number 2018060550; DYNDL1462B, Lot Number 2018100250; DYNDL1462B, Lot Number 2019022750; DYNDL1462B, Lot Number 2019041050; DYNDL1462B, Lot Number 2019080850; DYNDL1462B, Lot Number 2019100850; DYNDL1462B, Lot Number 2019102950; DYNDL1462B, Lot Number 2020041650; DYNDL1462B, Lot Number 2020092850; DYNDL1462B, Lot Number 2021031850; DYNDL1462B, Lot Number 2021050650; DYNDL1462B, Lot Number 2021062450; DYNDL1462B, Lot Number 2021100650; DYNDL1462B, Lot Number 2022021050; DYNDL1569A, Lot Number 2018061990; DYNDL1569A, Lot Number 2018062790; DYNDL1569A, Lot Number 2018072390; DYNDL1569A, Lot Number 2018081590; DYNDL1569A, Lot Number 2019032090; DYNDL1569A, Lot Number 2019051390; DYNDL1569A, Lot Number 2019081690; DYNDL1569A, Lot Number 2019092690; DYNDL1569A, Lot Number 2019112290; DYNDL1569A, Lot Number 2020022690; DYNDL1571B, Lot Number 2019030690; DYNDL1571B, Lot Number 2019100290; DYNDL1571B, Lot Number 2020010790; DYNDL1722, Lot Number 2019060390; DYNDL1739, Lot Number 2018111290; DYNDL1739, Lot Number 2019020890; DYNDL1739, Lot Number 2019032790; DYNDL1739, Lot Number 2019062190; DYNDL1757, Lot Number 2019071790; DYNDL1757, Lot Number 2020010790; DYNDL1772, Lot Number 2018122190; DYNDL1772, Lot Number 2019041690; DYNDL1772, Lot Number 2019051690; DYNDL1772, Lot Number 2019082290; DYNDL1772, Lot Number 2019091990; DYNDL1772, Lot Number 2019102590; DYNDL1772, Lot Number 2020031190; DYNDL1774A, Lot Number 2019010390; DYNDL1774A, Lot Number 2019012990; DYNDL1774A, Lot Number 2019061790; DYNDL1774A, Lot Number 2019081290; DYNDL1774A, Lot Number 2019102290; DYNDL1774A, Lot Number 2019120690; DYNDL1774A, Lot Number 2020021490; DYNDL1887, Lot Number 2019042390; DYNDL1887, Lot Number 2019061290; DYNDL1887, Lot Number 2019090490; DYNDL1898, Lot Number 2019021250; DYNDL1898, Lot Number 2019032050; DYNDL1898, Lot Number 2019040250; DYNDL2952, Lot Number 2020052890; DYNDL2952, Lot Number 2020092490; DYNDL2952, Lot Number 2021072790; DYNDL2952, Lot Number 2021081290; DYNDL2952, Lot Number 2021090690; DYNDL2952, Lot Number 2021101490; DYNDL2952, Lot Number 2022041490; DYNDL2952, Lot Number 2022052390; DYNDL2952, Lot Number 2022071890; DYNDL2952, Lot Number 2022120790; DYNDL2952, Lot Number 2023050890; DYNDL2952, Lot Number 2023062090; DYNDL2952, Lot Number 2023102490; DYNDS1064B, Lot Number 2019042980; DYNDS1064B, Lot Number 2019082680; DYNDS1064B, Lot Number 2019093080; DYNDS1064B, Lot Number 2020022480; DYNDV1588F, Lot Number 2019102590; DYNJ04162, Lot Number 23BBE128 ; DYNJ04162, Lot Number 23CBQ393 ; DYNJ04162, Lot Number 23CBV205 ; DYNJ04162, Lot Number 23EBE121 ; DYNJ04162, Lot Number 23FBF865 ; DYNJ04162, Lot Number 23GBR313 ; DYNJ04162, Lot Number 23HBX269 ; DYNJ04162, Lot Number 23HBZ391 ; DYNJ04162, Lot Number 23IBP884 ; DYNJ04162, Lot Number 23KBM597 ; DYNJ04162H , Lot Number 23BBE128 ; DYNJ04162H , Lot Number 23CBQ393 ; DYNJ04162H , Lot Number 23CBV205 ; DYNJ04162H , Lot Number 23EBE121 ; DYNJ04162H , Lot Number 23FBF865 ; DYNJ04162H , Lot Number 23GBR313 ; DYNJ04162H , Lot Number 23HBX269 ; DYNJ04162H , Lot Number 23HBZ391 ; DYNJ04162H , Lot Number 23IBP884 ; DYNJ04162H , Lot Number 23KBM597 ; DYNJ05162, Lot Number 2019111350; DYNJ05162, Lot Number 2020110550; DYNJ05162, Lot Number 2021012750; DYNJ05162, Lot Number 2021042750; DYNJ36762A , Lot Number 21FLA929 ; DYNJ36762A , Lot Number 21ILA164 ; DYNJ36762A , Lot Number 21ILA986 ; DYNJ36762A , Lot Number 21JLA315 ; DYNJ36762A , Lot Number 21KLA005 ; DYNJ36762A , Lot Number 21KLA162 ; DYNJ36762A , Lot Number 21KLA629 ; DYNJ36762A , Lot Number 22FLA472 ; DYNJ36762A , Lot Number 22ILA678 ; DYNJ36762A , Lot Number 22KLA066 ; DYNJ36762A , Lot Number 23CLA135 ; DYNJ36762A , Lot Number 23DLA436 ; DYNJ36762A , Lot Number 23ELA127 ; DYNJ36762A , Lot Number 23FLA622 ; DYNJ36762A , Lot Number 23GLA417 ; DYNJ36762A , Lot Number 23KLA169 ; DYNJ36762A , Lot Number 23KLB162 ; DYNJ36762AH, Lot Number 21FLA929 ; DYNJ36762AH, Lot Number 21ILA164 ; DYNJ36762AH, Lot Number 21ILA986 ; DYNJ36762AH, Lot Number 21JLA315 ; DYNJ36762AH, Lot Number 21KLA005 ; DYNJ36762AH, Lot Number 21KLA162 ; DYNJ36762AH, Lot Number 21KLA629 ; DYNJ36762AH, Lot Number 22FLA472 ; DYNJ36762AH, Lot Number 22ILA678 ; DYNJ36762AH, Lot Number 22KLA066 ; DYNJ36762AH, Lot Number 23CLA135 ; DYNJ36762AH, Lot Number 23DLA436 ; DYNJ36762AH, Lot Number 23ELA127 ; DYNJ36762AH, Lot Number 23FLA622 ; DYNJ36762AH, Lot Number 23GLA417 ; DYNJ36762AH, Lot Number 23KLA169 ; DYNJ36762AH, Lot Number 23KLB162 ; DYNJRA0659, Lot Number 2019050690; DYNJRA0659, Lot Number 2019071590; DYNJTS0018A, Lot Number 2020041450; DYNJTS0018A, Lot Number 2020102150; DYNJTS0018A, Lot Number 2021051750; DYNJTS0036, Lot Number 2018091350; DYNJTS0036, Lot Number 2018112650; DYNJTS0036, Lot Number 2019010750; DYNJTS0036, Lot Number 2019042350; DYNJTS0036, Lot Number 2019051050; DYNJTS0214, Lot Number 2020092950; DYNJTS0214, Lot Number 2021031250; DYNJTS0214, Lot Number 2021072650; DYNJTS0214, Lot Number 2022062890; DYNJTS04035, Lot Number 2019120250; DYNJTS04035, Lot Number 2019120250; DYNJTS04035, Lot Number 2020082550; DYNJTS04035, Lot Number 2020091850; DYNJTS04035, Lot Number 2020102350; DYNJTS04035, Lot Number 2020120950; DYNJTS04035, Lot Number 2021012250; DYNJTS0404A, Lot Number 2019112750; DYNJTS0404A, Lot Number 2020062550; DYNJTS0404A, Lot Number 2020072450; DYNJTS0404A, Lot Number 2020080450; DYNJTS0404A, Lot Number 2020081750; DYNJTS0404A, Lot Number 2021062550; DYNJTS0404A, Lot Number 2021072050; DYNJTS0404A, Lot Number 2022011350; DYNJTS0404A, Lot Number 2022041150; DYNJTS0512, Lot Number 2021041150; DYNJTS0512, Lot Number 2021051550; DYNJTS0512, Lot Number 2021061150; DYNJTS0512, Lot Number 2021072950; DYNJTS0512, Lot Number 2021082050; DYNJTS0512, Lot Number 2021092650; DYNJTS0512, Lot Number 2021120450; DYNJTS0512, Lot Number 2022011050; DYNJTS0512, Lot Number 2022012850; DYNJTS0512, Lot Number 2022021350; DYNJTS0512, Lot Number 2022022850; DYNJTS0512, Lot Number 2022032350; DYNJTS0514, Lot Number 2020100850; DYNJTS0514, Lot Number 2021051750; DYNJTS0514, Lot Number 2021070850; DYNJTS0514, Lot Number 2021100650; DYNJTS0514, Lot Number 2022060350; DYNJTS07025, Lot Number 2020052950; DYNJTS07035, Lot Number 2021062850; DYNJTS07035, Lot Number 2021070850; DYNJTS07035, Lot Number 2021072650; DYNJTS07035, Lot Number 2021080450; DYNJTS07035, Lot Number 2021082050; DYNJTS07035, Lot Number 2021082350; DYNJTS07035, Lot Number 2022020450; DYNJTS2343T, Lot Number 2020090150; DYNJTS2343T, Lot Number 2020101650; DYNJTS2343T, Lot Number 2021012750; DYNJTS2343T, Lot Number 2021030450; DYNJTS2343T, Lot Number 2021061550; DYNJTS2343T, Lot Number 2021072650; DYNJTS2343T, Lot Number 2022011250; DYNJTS2343T, Lot Number 2022060250; DYNJTS4301, Lot Number 2020102250; DYNJTS4301, Lot Number 2020102250; DYNJTS4301, Lot Number 2021060750; DYNJTS4301, Lot Number 2021072950; DYNJTS4302, Lot Number 2021121450; DYNJTS4306, Lot Number 2020110550; DYNJTS4306, Lot Number 2021032550; DYNJTS4306, Lot Number 2021061150; DYNJTS8100, Lot Number 2020111950; EBSI1241, Lot Number 2023032490; ECVC8050, Lot Number 2023031590; GSC065DB, Lot Number 2019020890; GSC065DB, Lot Number 2019040490; GSC065DB, Lot Number 2019050890; GSC065DB, Lot Number 2019072490; GSC065DB, Lot Number 2019092490; GSC065DB, Lot Number 2019110590; GSC065DB, Lot Number 2020021190; KABX01B, Lot Number 2019022050; M101346B, Lot Number 2019080790; M101346B, Lot Number 2019092490; M101346B, Lot Number 2019111990; M101347B, Lot Number 2019110590; M101347B, Lot Number 2019120290; MNS10875A, Lot Number 2023080190; MNS11020A, Lot Number 2019082290; MNS11020A, Lot Number 2021040590; MNS11020A, Lot Number 2022022890; MNS11590, Lot Number 2019061790; MNS11590, Lot Number 2019090590; MNS12670A, Lot Number 2021040590; MNS12670A, Lot Number 2022030490; MNS12700, Lot Number 2022083190; MNS3345A, Lot Number 23KBG041; MNS3345A, Lot Number 23GBI070; MNS3345A, Lot Number 23EBU454; MNS3345A, Lot Number 23DBE660; MNS3345A, Lot Number 22KBU038; MNS3355, Lot Number 2019120290; MNS4815, Lot Number 2022082290; MNS4815, Lot Number 2023111690; MNS5155, Lot Number 23KBL485; MNS5155, Lot Number 23JBB317; MNS5155H, Lot Number 23KBL485; MNS5155H, Lot Number 23JBB317; MNS5460, Lot Number 2019091890; MNS5460, Lot Number 21GBS365 ; MNS5460, Lot Number 21IBI307 ; MNS5460, Lot Number 21IBI353 ; MNS5460, Lot Number 21JBZ924 ; MNS5460, Lot Number 21KBN192 ; MNS5460, Lot Number 21LBS510 ; MNS5460, Lot Number 22FBM311 ; MNS5460, Lot Number 22HBQ067 ; MNS5460, Lot Number 22IBV082 ; MNS5460, Lot Number 22JBU758 ; MNS5460, Lot Number 22KBJ182 ; MNS5460, Lot Number 23GBJ025 ; MNS5460, Lot Number 21BBC358 ; MNS5460, Lot Number 21BBC387 ; MNS5460, Lot Number 21EBB603 ; MNS5575, Lot Number 2019083090; MNS5575, Lot Number 2019112290; MNS6465, Lot Number 2018071990; MNS6465, Lot Number 2022082290; MNS6496, Lot Number 2018092790; MNS6496, Lot Number 2019111390; MNS6496, Lot Number 2020121090; MNS6496, Lot Number 2022051390; MNS6496, Lot Number 2023112290; MNS8340, Lot Number 21IBI310 ; MNS8340, Lot Number 21JBT679 ; MNS8340, Lot Number 21LBJ253 ; MNS8340, Lot Number 22ABX842 ; MNS8340, Lot Number 22EBB220 ; MNS8340, Lot Number 22FBA468 ; MNS8340, Lot Number 22JBW906 ; MNS8340, Lot Number 23BBP316 ; MNS8340, Lot Number 23FBA607 ; MNS8340, Lot Number 23HBS668 ; MNS8340, Lot Number 21CBY113 ; MNS8340, Lot Number 21EBF560 ; MNS9580, Lot Number 2020121090; MNS9580, Lot Number 2023091290; MNS9580, Lot Number 2023112190; MNS9860, Lot Number 21JBI244 ; MNS9860, Lot Number 21JBX202 ; MNS9860, Lot Number 21LBL877 ; MNS9860, Lot Number 22FBN120 ; MNS9860, Lot Number 22HBO387 ; MNS9860, Lot Number 22HBY603 ; MNS9860, Lot Number 22JBB962 ; MNS9860, Lot Number 22KBA809 ; P151659, Lot Number 2018100890; P151659, Lot Number 2019060790; P151659, Lot Number 2019073190; P151659, Lot Number 2020030290; P241108, Lot Number 2018052150; P241108, Lot Number 2018062250; P241108, Lot Number 2018080150; P241108, Lot Number 2018112750; P241108, Lot Number 2019020750; P241108, Lot Number 2019032250; P241108, Lot Number 2019050350; P241108, Lot Number 2019060450; P241108, Lot Number 2019090550; P241108, Lot Number 2019120950; P241108, Lot Number 2020041450; P241108, Lot Number 2020092950; P241108, Lot Number 2021032550; P241108, Lot Number 2021060750; P241108, Lot Number 2022052550; P268481, Lot Number 2019071250; P268481, Lot Number 2020062550; P42. A RECORDED FDA enforcement action (occurred=true).
openFDA drug & device enforcement (recall) reports — U.S. FDA
A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.
FDA classified recall Z-3020-2024 as Class II
The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
U.S. FDA recall classification (openFDA enforcement)
occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.
A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.
Ongoing — the recall is still being carried out.
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.