Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY CDS, Pack Number CDS780025Y ; 12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ; 13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ; 14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ; 15) CRANIOTOMY CDS, Pack Number CDS780046O ; 16) CRANI , Pack Number CDS780089V ; 17) CRANI , Pack Number CDS780089W ; 18) CRANI , Pack Number CDS780089X ; 19) CRANIOFACIAL CDS, Pack Number CDS780102K ; 20) CRANIOFACIAL CDS, Pack Number CDS780102L ; 21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ; 22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ; 23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ; 24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ; 25) CRANIOTOMY-LF , Pack Number CDS780111M ; 26) CRANIOTOMY-LF , Pack Number CDS780111N ; 27) CRANIOTOMY-LF , Pack Number CDS780111O ; 28) CRANIOTOMY-LF , Pack Number CDS780111P ; 29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ; 30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ; 31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH; 32) BASIC BACK CDS, Pack Number CDS780147K ; 33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ; 34) LAMINECTOMY CDS , Pack Number CDS780165L ; 35) LAMINECTOMY CDS , Pack Number CDS780165M ; 36) LAMINECTOMY CDS , Pack Number CDS780165N ; 37) LAMINECTOMY CDS , Pack Number CDS780165O ; 38) LAMINECTOMY CDS , Pack Number CDS780165Q ; 39) LAMINECTOMY CDS , Pack Number CDS780165R ; 40) CRANIOTOMY CDS, Pack Number CDS780166Q ; 41) CRANIOTOMY CDS, Pack Number CDS780166R ; 42) CRANIOTOMY CDS, Pack Number CDS780166S ; 43) CRANIOTOMY CDS, Pack Number CDS780166T ; 44) CRANIOTOMY CDS, Pack Number CDS780166U ; 45) CRANIOTOMY CDS, Pack Number CDS780166V ; 46) DR WOLF SPINE CDS , Pack Number CDS780168P ; 47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ; 48) SPINAL FUSION CDS , Pack Number CDS780197N ; 49) SPINAL FUSION PACK, Pack Number CDS780197P ; 50) SPINAL FUSION PACK, Pack Number CDS780197Q ; 51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ; 52) LAMINECTOMY CDS , Pack Number CDS780203J ; 53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ; 54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ; 55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ; 56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ; 57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ; 58) CRANIOTOMY CDS, Pack Number CDS780206O ; 59) CRANIOTOMY CDS, Pack Number CDS780206P ; 60) CRANIOTOMY CDS, Pack Number CDS780206R ; 61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ; 62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ; 63) NEURO-LAMI CDS, Pack Number CDS780208I ; 64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ; 65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ; 66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ; 67) SPINE CDS , Pack Number CDS780228D ; 68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ; 69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ; 70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ; 71) SPINE CDS-LF, Pack Number CDS780236L ; 72) SPINE CDS-LF, Pack Number CDS780236M ; 73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ; 74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ; 75) SPINAL FUSION , Pack Number CDS860017AA; 76) SPINAL FUSION , Pack Number CDS860017AB; 77) SPINAL FUSION , Pack Number CDS860017AC; 78) FUSION CDS, Pack Number CDS860138D ; 79) FUSION CDS, Pack Number CDS860138F ; 80) FUSION CDS, Pack Number CDS860138G ; 81) LUMBAR, Pack Number CDS860170I ; 82) LUMBAR, Pack Number CDS860170J ; 83) LUMBAR, Pack Numbe
FDA recall Z-3052-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY CDS, Pack Number CDS780025Y ; 12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ; 13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ; 14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ; 15) CRANIOTOMY CDS, Pack Number CDS780046O ; 16) CRANI , Pack Number CDS780089V ; 17) CRANI , Pack Number CDS780089W ; 18) CRANI , Pack Number CDS780089X ; 19) CRANIOFACIAL CDS, Pack Number CDS780102K ; 20) CRANIOFACIAL CDS, Pack Number CDS780102L ; 21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ; 22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ; 23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ; 24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ; 25) CRANIOTOMY-LF , Pack Number CDS780111M ; 26) CRANIOTOMY-LF , Pack Number CDS780111N ; 27) CRANIOTOMY-LF , Pack Number CDS780111O ; 28) CRANIOTOMY-LF , Pack Number CDS780111P ; 29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ; 30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ; 31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH; 32) BASIC BACK CDS, Pack Number CDS780147K ; 33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ; 34) LAMINECTOMY CDS , Pack Number CDS780165L ; 35) LAMINECTOMY CDS , Pack Number CDS780165M ; 36) LAMINECTOMY CDS , Pack Number CDS780165N ; 37) LAMINECTOMY CDS , Pack Number CDS780165O ; 38) LAMINECTOMY CDS , Pack Number CDS780165Q ; 39) LAMINECTOMY CDS , Pack Number CDS780165R ; 40) CRANIOTOMY CDS, Pack Number CDS780166Q ; 41) CRANIOTOMY CDS, Pack Number CDS780166R ; 42) CRANIOTOMY CDS, Pack Number CDS780166S ; 43) CRANIOTOMY CDS, Pack Number CDS780166T ; 44) CRANIOTOMY CDS, Pack Number CDS780166U ; 45) CRANIOTOMY CDS, Pack Number CDS780166V ; 46) DR WOLF SPINE CDS , Pack Number CDS780168P ; 47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ; 48) SPINAL FUSION CDS , Pack Number CDS780197N ; 49) SPINAL FUSION PACK, Pack Number CDS780197P ; 50) SPINAL FUSION PACK, Pack Number CDS780197Q ; 51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ; 52) LAMINECTOMY CDS , Pack Number CDS780203J ; 53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ; 54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ; 55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ; 56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ; 57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ; 58) CRANIOTOMY CDS, Pack Number CDS780206O ; 59) CRANIOTOMY CDS, Pack Number CDS780206P ; 60) CRANIOTOMY CDS, Pack Number CDS780206R ; 61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ; 62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ; 63) NEURO-LAMI CDS, Pack Number CDS780208I ; 64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ; 65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ; 66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ; 67) SPINE CDS , Pack Number CDS780228D ; 68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ; 69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ; 70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ; 71) SPINE CDS-LF, Pack Number CDS780236L ; 72) SPINE CDS-LF, Pack Number CDS780236M ; 73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ; 74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ; 75) SPINAL FUSION , Pack Number CDS860017AA; 76) SPINAL FUSION , Pack Number CDS860017AB; 77) SPINAL FUSION , Pack Number CDS860017AC; 78) FUSION CDS, Pack Number CDS860138D ; 79) FUSION CDS, Pack Number CDS860138F ; 80) FUSION CDS, Pack Number CDS860138G ; 81) LUMBAR, Pack Number CDS860170I ; 82) LUMBAR, Pack Number CDS860170J ; 83) LUMBAR, Pack Numbe (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-3052-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY CDS, Pack Number CDS780025Y ; 12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ; 13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ; 14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ; 15) CRANIOTOMY CDS, Pack Number CDS780046O ; 16) CRANI , Pack Number CDS780089V ; 17) CRANI , Pack Number CDS780089W ; 18) CRANI , Pack Number CDS780089X ; 19) CRANIOFACIAL CDS, Pack Number CDS780102K ; 20) CRANIOFACIAL CDS, Pack Number CDS780102L ; 21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ; 22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ; 23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ; 24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ; 25) CRANIOTOMY-LF , Pack Number CDS780111M ; 26) CRANIOTOMY-LF , Pack Number CDS780111N ; 27) CRANIOTOMY-LF , Pack Number CDS780111O ; 28) CRANIOTOMY-LF , Pack Number CDS780111P ; 29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ; 30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ; 31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH; 32) BASIC BACK CDS, Pack Number CDS780147K ; 33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ; 34) LAMINECTOMY CDS , Pack Number CDS780165L ; 35) LAMINECTOMY CDS , Pack Number CDS780165M ; 36) LAMINECTOMY CDS , Pack Number CDS780165N ; 37) LAMINECTOMY CDS , Pack Number CDS780165O ; 38) LAMINECTOMY CDS , Pack Number CDS780165Q ; 39) LAMINECTOMY CDS , Pack Number CDS780165R ; 40) CRANIOTOMY CDS, Pack Number CDS780166Q ; 41) CRANIOTOMY CDS, Pack Number CDS780166R ; 42) CRANIOTOMY CDS, Pack Number CDS780166S ; 43) CRANIOTOMY CDS, Pack Number CDS780166T ; 44) CRANIOTOMY CDS, Pack Number CDS780166U ; 45) CRANIOTOMY CDS, Pack Number CDS780166V ; 46) DR WOLF SPINE CDS , Pack Number CDS780168P ; 47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ; 48) SPINAL FUSION CDS , Pack Number CDS780197N ; 49) SPINAL FUSION PACK, Pack Number CDS780197P ; 50) SPINAL FUSION PACK, Pack Number CDS780197Q ; 51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ; 52) LAMINECTOMY CDS , Pack Number CDS780203J ; 53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ; 54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ; 55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ; 56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ; 57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ; 58) CRANIOTOMY CDS, Pack Number CDS780206O ; 59) CRANIOTOMY CDS, Pack Number CDS780206P ; 60) CRANIOTOMY CDS, Pack Number CDS780206R ; 61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ; 62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ; 63) NEURO-LAMI CDS, Pack Number CDS780208I ; 64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ; 65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ; 66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ; 67) SPINE CDS , Pack Number CDS780228D ; 68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ; 69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ; 70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ; 71) SPINE CDS-LF, Pack Number CDS780236L ; 72) SPINE CDS-LF, Pack Number CDS780236M ; 73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ; 74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ; 75) SPINAL FUSION , Pack Number CDS860017AA; 76) SPINAL FUSION , Pack Number CDS860017AB; 77) SPINAL FUSION , Pack Number CDS860017AC; 78) FUSION CDS, Pack Number CDS860138D ; 79) FUSION CDS, Pack Number CDS860138F ; 80) FUSION CDS, Pack Number CDS860138G ; 81) LUMBAR, Pack Number CDS860170I ; 82) LUMBAR, Pack Number CDS860170J ; 83) LUMBAR, Pack Numbe
The FDA logged enforcement record Z-3052-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY CDS, Pack Number CDS780025Y ; 12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ; 13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ; 14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ; 15) CRANIOTOMY CDS, Pack Number CDS780046O ; 16) CRANI , Pack Number CDS780089V ; 17) CRANI , Pack Number CDS780089W ; 18) CRANI , Pack Number CDS780089X ; 19) CRANIOFACIAL CDS, Pack Number CDS780102K ; 20) CRANIOFACIAL CDS, Pack Number CDS780102L ; 21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ; 22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ; 23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ; 24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ; 25) CRANIOTOMY-LF , Pack Number CDS780111M ; 26) CRANIOTOMY-LF , Pack Number CDS780111N ; 27) CRANIOTOMY-LF , Pack Number CDS780111O ; 28) CRANIOTOMY-LF , Pack Number CDS780111P ; 29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ; 30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ; 31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH; 32) BASIC BACK CDS, Pack Number CDS780147K ; 33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ; 34) LAMINECTOMY CDS , Pack Number CDS780165L ; 35) LAMINECTOMY CDS , Pack Number CDS780165M ; 36) LAMINECTOMY CDS , Pack Number CDS780165N ; 37) LAMINECTOMY CDS , Pack Number CDS780165O ; 38) LAMINECTOMY CDS , Pack Number CDS780165Q ; 39) LAMINECTOMY CDS , Pack Number CDS780165R ; 40) CRANIOTOMY CDS, Pack Number CDS780166Q ; 41) CRANIOTOMY CDS, Pack Number CDS780166R ; 42) CRANIOTOMY CDS, Pack Number CDS780166S ; 43) CRANIOTOMY CDS, Pack Number CDS780166T ; 44) CRANIOTOMY CDS, Pack Number CDS780166U ; 45) CRANIOTOMY CDS, Pack Number CDS780166V ; 46) DR WOLF SPINE CDS , Pack Number CDS780168P ; 47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ; 48) SPINAL FUSION CDS , Pack Number CDS780197N ; 49) SPINAL FUSION PACK, Pack Number CDS780197P ; 50) SPINAL FUSION PACK, Pack Number CDS780197Q ; 51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ; 52) LAMINECTOMY CDS , Pack Number CDS780203J ; 53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ; 54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ; 55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ; 56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ; 57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ; 58) CRANIOTOMY CDS, Pack Number CDS780206O ; 59) CRANIOTOMY CDS, Pack Number CDS780206P ; 60) CRANIOTOMY CDS, Pack Number CDS780206R ; 61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ; 62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ; 63) NEURO-LAMI CDS, Pack Number CDS780208I ; 64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ; 65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ; 66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ; 67) SPINE CDS , Pack Number CDS780228D ; 68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ; 69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ; 70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ; 71) SPINE CDS-LF, Pack Number CDS780236L ; 72) SPINE CDS-LF, Pack Number CDS780236M ; 73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ; 74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ; 75) SPINAL FUSION , Pack Number CDS860017AA; 76) SPINAL FUSION , Pack Number CDS860017AB; 77) SPINAL FUSION , Pack Number CDS860017AC; 78) FUSION CDS, Pack Number CDS860138D ; 79) FUSION CDS, Pack Number CDS860138F ; 80) FUSION CDS, Pack Number CDS860138G ; 81) LUMBAR, Pack Number CDS860170I ; 82) LUMBAR, Pack Number CDS860170J ; 83) LUMBAR, Pack Numbe — 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: 00-399024X , Lot Number 19CBL066 ; 00-399024X , Lot Number 19FBI397 ; 00-399024X , Lot Number 19RBC685 ; 00-399024X , Lot Number 19HBD864 ; 00-399024X , Lot Number 19JBV149 ; 00-399024X , Lot Number 20ABH766 ; 00-399024X , Lot Number 20ABO115 ; 00-399024X , Lot Number 20CBC862 ; AM110A , Lot Number 21GBK629 ; AM110A , Lot Number 19HBC424 ; AM110A , Lot Number 19JBR312 ; AM110A , Lot Number 19KBL415 ; AM110A , Lot Number 20ABK847 ; AM110A , Lot Number 20GBU689 ; AM110A , Lot Number 20HBK170 ; AM110A , Lot Number 20LBN052 ; AM110A , Lot Number 20LBW697 ; AM110A , Lot Number 21CBB960 ; AM110A , Lot Number 21FBC989 ; BM200A , Lot Number 19EBU942 ; BM230A , Lot Number 22CBC356 ; BM230A , Lot Number 19DBJ049 ; BM230A , Lot Number 19UBA244 ; BM230A , Lot Number 19JBQ486 ; BM230A , Lot Number 20DBF398 ; BM230A , Lot Number 20IBB552 ; BM230A , Lot Number 20JBR898 ; BM240A , Lot Number 21IBR974 ; BM240A , Lot Number 22BBC921 ; BM240A , Lot Number 19CBF549 ; BM240A , Lot Number 19EBV048 ; BM240A , Lot Number 20DBS054 ; BM240A , Lot Number 20GBU725 ; BM240A , Lot Number 20KBS381 ; BM240A , Lot Number 20KBX781 ; BM240A , Lot Number 21BBJ873 ; BM240A , Lot Number 21DBI364 ; BM250A , Lot Number 21LBI573 ; BM250A , Lot Number 22EBQ666 ; BM250A , Lot Number 19HBG435 ; BM250A , Lot Number 19JBD740 ; BM250A , Lot Number 20ABK834 ; BM250A , Lot Number 20DBR991 ; BM250A , Lot Number 20EBT982 ; BM250A , Lot Number 20GBC494 ; BM250A , Lot Number 20GBN979 ; BM250A , Lot Number 23LBT030 ; BM250A , Lot Number 20KBA693 ; BM250A , Lot Number 21ABA267 ; BM250A , Lot Number 21ABF688 ; BM250A , Lot Number 21BBM607 ; CDS780025AA, Lot Number 21ABG344 ; CDS780025AA, Lot Number 21BBI957 ; CDS780025AA, Lot Number 21CBD927 ; CDS780025AB, Lot Number 21HBL624 ; CDS780025AB, Lot Number 21IBL720 ; CDS780025AB, Lot Number 21LBU758 ; CDS780025AB, Lot Number 22CBP174 ; CDS780025AB, Lot Number 22EBN090 ; CDS780025AB, Lot Number 22GBH493 ; CDS780025AB, Lot Number 22HBB637 ; CDS780025AC, Lot Number 22LBF788 ; CDS780025AC, Lot Number 23CBX130 ; CDS780025AC, Lot Number 23EBJ659 ; CDS780025AC, Lot Number 23FBH173 ; CDS780025AC, Lot Number 23IBI612 ; CDS780025AC, Lot Number 23KBC083 ; CDS780025AC, Lot Number 24BBB443 ; CDS780025X , Lot Number 19ABP155 ; CDS780025X , Lot Number 19ABQ093 ; CDS780025X , Lot Number 19ABY942 ; CDS780025X , Lot Number 19CBE111 ; CDS780025X , Lot Number 19FBV023 ; CDS780025Y , Lot Number 19EBO302 ; CDS780025Y , Lot Number 19EBO396 ; CDS780025Y , Lot Number 19KBQ760 ; CDS780025Y , Lot Number 19KBU716 ; CDS780025Y , Lot Number 19LBF130 ; CDS780025Y , Lot Number 20DBO129 ; CDS780025Y , Lot Number 20GBQ281 ; CDS780025Y , Lot Number 20GBS047 ; CDS780025Y , Lot Number 20JBY248 ; CDS780045M , Lot Number 19BBH900 ; CDS780045M , Lot Number 19CBC615 ; CDS780045M , Lot Number 19DBC309 ; CDS780045M , Lot Number 19EBU628 ; CDS780045M , Lot Number 19EBU835 ; CDS780045M , Lot Number 19GBR400 ; CDS780045M , Lot Number 19SBC898 ; CDS780045M , Lot Number 19VBE307 ; CDS780045M , Lot Number 19KBN002 ; CDS780045M , Lot Number 19KBT829 ; CDS780045M , Lot Number 20BBJ961 ; CDS780045M , Lot Number 20CBP221 ; CDS780045N , Lot Number 21FBL891 ; CDS780045N , Lot Number 21FBS507 ; CDS780045N , Lot Number 21JBU289 ; CDS780045N , Lot Number 21LBP574 ; CDS780045N , Lot Number 22DBA187 ; CDS780045N , Lot Number 22DBB694 ; CDS780045N , Lot Number 22FBM376 ; CDS780045N , Lot Number 22GBG444 ; CDS780045N , Lot Number 22GBG445 ; CDS780045N , Lot Number 22JBI816 ; CDS780045N , Lot Number 22JBI817 ; CDS780045N , Lot Number 22LBP661 ; CDS780045N , Lot Number 23CBR748 ; CDS780045N , Lot Number 20GBC500 ; CDS780045N , Lot Number 20GBD251 ; CDS780045N , Lot Number 20GBL415 ; CDS780045N , Lot Number 20GBQ383 ; CDS780045N , Lot Number 20IBN736 ; CDS780045N , Lot Number 20JBX378 ; CDS780045N , Lot Number 20LBC750 ; CDS780045N , Lot Number 21BBF167 ; CDS780045O , Lot Number 23DBP671 ; CDS780045O , Lot Number 23EBT969 ; CDS780045O , Lot Number 23FBU385 ; CDS780046O , Lot Number 21GBR876 ; CDS780046O , Lot Number 22ABW880 ; 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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-3052-2024 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.
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