Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Number CDS810023I; 7) RETINA-LF, Pack Number CDS810023J; 8) RETINA-LF, Pack Number CDS810023K; 9) EYE CDS , Pack Number CDS810032L ; 10) EYE CDS , Pack Number CDS810032M ; 11) EYE CDS , Pack Number CDS810032N ; 12) EYE CDS , Pack Number CDS810032O ; 13) GENERAL EYE , Pack Number CDS981693I ; 14) GENERAL EYE , Pack Number CDS981693J ; 15) EYE CDS II, Pack Number CDS981738A ; 16) MUSCLE/EYE CDS, Pack Number CDS982059F ; 17) MUSCLE/EYE CDS, Pack Number CDS982059G ; 18) MUSCLE/EYE CDS, Pack Number CDS982059I ; 19) CATARACT CDS-4, Pack Number CDS983001F ; 20) VITRECTOMY CDS-4, Pack Number CDS983005F ; 21) PTERYGIUM CDS , Pack Number CDS983261D ; 22) PTERYGIUM CDS , Pack Number CDS983261F ; 23) PTERYGIUM CDS , Pack Number CDS983261G ; 24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ; 25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ; 26) RETINA LAC/USC CDS, Pack Number CDS983775I; 27) EYE CDS , Pack Number CDS983916F ; 28) EYE CDS , Pack Number CDS983916G ; 29) CATH CDS, Pack Number CDS984141G ; 30) CATARACT CDS, Pack Number CDS984159C ; 31) CATARACT CDS, Pack Number CDS984159D ; 32) CATARACT CDS, Pack Number CDS984159G ; 33) CATARACT CDS, Pack Number CDS984159I ; 34) VITRECTOMY, Pack Number CDS984258J ; 35) VITRECTOMY, Pack Number CDS984258K ; 36) VITRECTOMY, Pack Number CDS984258L ; 37) CATARACT CDS, Pack Number CDS984343B ; 38) CATARACT CDS, Pack Number CDS984343C ; 39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ; 40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH; 41) EYE BANK PREP KIT , Pack Number DYNDA2345; 42) LASIK PACK, Pack Number DYNDA2925; 43) EYE PLASTIC KIT, Pack Number DYNDC3196; 44) BIOPSY TRAY , Pack Number DYNDH1854; 45) LACERATION TRAY , Pack Number DYNDL1990; 46) LASIK PACK, Pack Number DYNDM1087; 47) GLENNON EYE PACK, Pack Number DYNJ00098F ; 48) CATARACT PACK , Pack Number DYNJ00260K ; 49) INTRAOCULAR PACK, Pack Number DYNJ00260L ; 50) INTRAOCULAR PACK, Pack Number DYNJ00260M ; 51) EYEPACK , Pack Number DYNJ00874G ; 52) EYEPACK , Pack Number DYNJ00874I ; 53) EYEPACK , Pack Number DYNJ00874J ; 54) EYEPACK , Pack Number DYNJ00874K ; 55) MEC EYE PACK, Pack Number DYNJ0101578F ; 56) MEC EYE PACK, Pack Number DYNJ0101578G ; 57) MEC EYE PACK, Pack Number DYNJ0101578J ; 58) BR EYE PAC, Pack Number DYNJ0101578K ; 59) BR EYE PACK-LF, Pack Number DYNJ0101578L ; 60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ; 61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ; 62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ; 63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ; 64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ; 65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ; 66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ; 67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ; 68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ; 69) CATARACT PACK , Pack Number DYNJ01263G ; 70) CATARACT PACK , Pack Number DYNJ01263I ; 71) CATARACT PACK , Pack Number DYNJ01263J ; 72) CATARACT PACK-LF, Pack Number DYNJ0129784R ; 73) CATARACT PACK-LF, Pack Number DYNJ0129784RH; 74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ; 75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ; 76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ; 77) RETINAL PACK-LF , Pack Number DYNJ0151148B ; 78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ; 79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ; 80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ; 81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ; 82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ; 83) CATARACT PACK-LF, Pack Number DYNJ0159809B ; 84) EYE PACK, Pack Number DYNJ0168810Q ; 85) EYE PBM-LF, Pack Number DYNJ0190619F ; 86) EYE PBM-LF, Pack Num
FDA recall Z-3051-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Number CDS810023I; 7) RETINA-LF, Pack Number CDS810023J; 8) RETINA-LF, Pack Number CDS810023K; 9) EYE CDS , Pack Number CDS810032L ; 10) EYE CDS , Pack Number CDS810032M ; 11) EYE CDS , Pack Number CDS810032N ; 12) EYE CDS , Pack Number CDS810032O ; 13) GENERAL EYE , Pack Number CDS981693I ; 14) GENERAL EYE , Pack Number CDS981693J ; 15) EYE CDS II, Pack Number CDS981738A ; 16) MUSCLE/EYE CDS, Pack Number CDS982059F ; 17) MUSCLE/EYE CDS, Pack Number CDS982059G ; 18) MUSCLE/EYE CDS, Pack Number CDS982059I ; 19) CATARACT CDS-4, Pack Number CDS983001F ; 20) VITRECTOMY CDS-4, Pack Number CDS983005F ; 21) PTERYGIUM CDS , Pack Number CDS983261D ; 22) PTERYGIUM CDS , Pack Number CDS983261F ; 23) PTERYGIUM CDS , Pack Number CDS983261G ; 24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ; 25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ; 26) RETINA LAC/USC CDS, Pack Number CDS983775I; 27) EYE CDS , Pack Number CDS983916F ; 28) EYE CDS , Pack Number CDS983916G ; 29) CATH CDS, Pack Number CDS984141G ; 30) CATARACT CDS, Pack Number CDS984159C ; 31) CATARACT CDS, Pack Number CDS984159D ; 32) CATARACT CDS, Pack Number CDS984159G ; 33) CATARACT CDS, Pack Number CDS984159I ; 34) VITRECTOMY, Pack Number CDS984258J ; 35) VITRECTOMY, Pack Number CDS984258K ; 36) VITRECTOMY, Pack Number CDS984258L ; 37) CATARACT CDS, Pack Number CDS984343B ; 38) CATARACT CDS, Pack Number CDS984343C ; 39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ; 40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH; 41) EYE BANK PREP KIT , Pack Number DYNDA2345; 42) LASIK PACK, Pack Number DYNDA2925; 43) EYE PLASTIC KIT, Pack Number DYNDC3196; 44) BIOPSY TRAY , Pack Number DYNDH1854; 45) LACERATION TRAY , Pack Number DYNDL1990; 46) LASIK PACK, Pack Number DYNDM1087; 47) GLENNON EYE PACK, Pack Number DYNJ00098F ; 48) CATARACT PACK , Pack Number DYNJ00260K ; 49) INTRAOCULAR PACK, Pack Number DYNJ00260L ; 50) INTRAOCULAR PACK, Pack Number DYNJ00260M ; 51) EYEPACK , Pack Number DYNJ00874G ; 52) EYEPACK , Pack Number DYNJ00874I ; 53) EYEPACK , Pack Number DYNJ00874J ; 54) EYEPACK , Pack Number DYNJ00874K ; 55) MEC EYE PACK, Pack Number DYNJ0101578F ; 56) MEC EYE PACK, Pack Number DYNJ0101578G ; 57) MEC EYE PACK, Pack Number DYNJ0101578J ; 58) BR EYE PAC, Pack Number DYNJ0101578K ; 59) BR EYE PACK-LF, Pack Number DYNJ0101578L ; 60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ; 61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ; 62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ; 63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ; 64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ; 65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ; 66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ; 67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ; 68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ; 69) CATARACT PACK , Pack Number DYNJ01263G ; 70) CATARACT PACK , Pack Number DYNJ01263I ; 71) CATARACT PACK , Pack Number DYNJ01263J ; 72) CATARACT PACK-LF, Pack Number DYNJ0129784R ; 73) CATARACT PACK-LF, Pack Number DYNJ0129784RH; 74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ; 75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ; 76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ; 77) RETINAL PACK-LF , Pack Number DYNJ0151148B ; 78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ; 79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ; 80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ; 81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ; 82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ; 83) CATARACT PACK-LF, Pack Number DYNJ0159809B ; 84) EYE PACK, Pack Number DYNJ0168810Q ; 85) EYE PBM-LF, Pack Number DYNJ0190619F ; 86) EYE PBM-LF, Pack Num (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-3051-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Number CDS810023I; 7) RETINA-LF, Pack Number CDS810023J; 8) RETINA-LF, Pack Number CDS810023K; 9) EYE CDS , Pack Number CDS810032L ; 10) EYE CDS , Pack Number CDS810032M ; 11) EYE CDS , Pack Number CDS810032N ; 12) EYE CDS , Pack Number CDS810032O ; 13) GENERAL EYE , Pack Number CDS981693I ; 14) GENERAL EYE , Pack Number CDS981693J ; 15) EYE CDS II, Pack Number CDS981738A ; 16) MUSCLE/EYE CDS, Pack Number CDS982059F ; 17) MUSCLE/EYE CDS, Pack Number CDS982059G ; 18) MUSCLE/EYE CDS, Pack Number CDS982059I ; 19) CATARACT CDS-4, Pack Number CDS983001F ; 20) VITRECTOMY CDS-4, Pack Number CDS983005F ; 21) PTERYGIUM CDS , Pack Number CDS983261D ; 22) PTERYGIUM CDS , Pack Number CDS983261F ; 23) PTERYGIUM CDS , Pack Number CDS983261G ; 24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ; 25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ; 26) RETINA LAC/USC CDS, Pack Number CDS983775I; 27) EYE CDS , Pack Number CDS983916F ; 28) EYE CDS , Pack Number CDS983916G ; 29) CATH CDS, Pack Number CDS984141G ; 30) CATARACT CDS, Pack Number CDS984159C ; 31) CATARACT CDS, Pack Number CDS984159D ; 32) CATARACT CDS, Pack Number CDS984159G ; 33) CATARACT CDS, Pack Number CDS984159I ; 34) VITRECTOMY, Pack Number CDS984258J ; 35) VITRECTOMY, Pack Number CDS984258K ; 36) VITRECTOMY, Pack Number CDS984258L ; 37) CATARACT CDS, Pack Number CDS984343B ; 38) CATARACT CDS, Pack Number CDS984343C ; 39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ; 40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH; 41) EYE BANK PREP KIT , Pack Number DYNDA2345; 42) LASIK PACK, Pack Number DYNDA2925; 43) EYE PLASTIC KIT, Pack Number DYNDC3196; 44) BIOPSY TRAY , Pack Number DYNDH1854; 45) LACERATION TRAY , Pack Number DYNDL1990; 46) LASIK PACK, Pack Number DYNDM1087; 47) GLENNON EYE PACK, Pack Number DYNJ00098F ; 48) CATARACT PACK , Pack Number DYNJ00260K ; 49) INTRAOCULAR PACK, Pack Number DYNJ00260L ; 50) INTRAOCULAR PACK, Pack Number DYNJ00260M ; 51) EYEPACK , Pack Number DYNJ00874G ; 52) EYEPACK , Pack Number DYNJ00874I ; 53) EYEPACK , Pack Number DYNJ00874J ; 54) EYEPACK , Pack Number DYNJ00874K ; 55) MEC EYE PACK, Pack Number DYNJ0101578F ; 56) MEC EYE PACK, Pack Number DYNJ0101578G ; 57) MEC EYE PACK, Pack Number DYNJ0101578J ; 58) BR EYE PAC, Pack Number DYNJ0101578K ; 59) BR EYE PACK-LF, Pack Number DYNJ0101578L ; 60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ; 61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ; 62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ; 63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ; 64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ; 65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ; 66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ; 67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ; 68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ; 69) CATARACT PACK , Pack Number DYNJ01263G ; 70) CATARACT PACK , Pack Number DYNJ01263I ; 71) CATARACT PACK , Pack Number DYNJ01263J ; 72) CATARACT PACK-LF, Pack Number DYNJ0129784R ; 73) CATARACT PACK-LF, Pack Number DYNJ0129784RH; 74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ; 75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ; 76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ; 77) RETINAL PACK-LF , Pack Number DYNJ0151148B ; 78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ; 79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ; 80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ; 81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ; 82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ; 83) CATARACT PACK-LF, Pack Number DYNJ0159809B ; 84) EYE PACK, Pack Number DYNJ0168810Q ; 85) EYE PBM-LF, Pack Number DYNJ0190619F ; 86) EYE PBM-LF, Pack Num
The FDA logged enforcement record Z-3051-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Number CDS810023I; 7) RETINA-LF, Pack Number CDS810023J; 8) RETINA-LF, Pack Number CDS810023K; 9) EYE CDS , Pack Number CDS810032L ; 10) EYE CDS , Pack Number CDS810032M ; 11) EYE CDS , Pack Number CDS810032N ; 12) EYE CDS , Pack Number CDS810032O ; 13) GENERAL EYE , Pack Number CDS981693I ; 14) GENERAL EYE , Pack Number CDS981693J ; 15) EYE CDS II, Pack Number CDS981738A ; 16) MUSCLE/EYE CDS, Pack Number CDS982059F ; 17) MUSCLE/EYE CDS, Pack Number CDS982059G ; 18) MUSCLE/EYE CDS, Pack Number CDS982059I ; 19) CATARACT CDS-4, Pack Number CDS983001F ; 20) VITRECTOMY CDS-4, Pack Number CDS983005F ; 21) PTERYGIUM CDS , Pack Number CDS983261D ; 22) PTERYGIUM CDS , Pack Number CDS983261F ; 23) PTERYGIUM CDS , Pack Number CDS983261G ; 24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ; 25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ; 26) RETINA LAC/USC CDS, Pack Number CDS983775I; 27) EYE CDS , Pack Number CDS983916F ; 28) EYE CDS , Pack Number CDS983916G ; 29) CATH CDS, Pack Number CDS984141G ; 30) CATARACT CDS, Pack Number CDS984159C ; 31) CATARACT CDS, Pack Number CDS984159D ; 32) CATARACT CDS, Pack Number CDS984159G ; 33) CATARACT CDS, Pack Number CDS984159I ; 34) VITRECTOMY, Pack Number CDS984258J ; 35) VITRECTOMY, Pack Number CDS984258K ; 36) VITRECTOMY, Pack Number CDS984258L ; 37) CATARACT CDS, Pack Number CDS984343B ; 38) CATARACT CDS, Pack Number CDS984343C ; 39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ; 40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH; 41) EYE BANK PREP KIT , Pack Number DYNDA2345; 42) LASIK PACK, Pack Number DYNDA2925; 43) EYE PLASTIC KIT, Pack Number DYNDC3196; 44) BIOPSY TRAY , Pack Number DYNDH1854; 45) LACERATION TRAY , Pack Number DYNDL1990; 46) LASIK PACK, Pack Number DYNDM1087; 47) GLENNON EYE PACK, Pack Number DYNJ00098F ; 48) CATARACT PACK , Pack Number DYNJ00260K ; 49) INTRAOCULAR PACK, Pack Number DYNJ00260L ; 50) INTRAOCULAR PACK, Pack Number DYNJ00260M ; 51) EYEPACK , Pack Number DYNJ00874G ; 52) EYEPACK , Pack Number DYNJ00874I ; 53) EYEPACK , Pack Number DYNJ00874J ; 54) EYEPACK , Pack Number DYNJ00874K ; 55) MEC EYE PACK, Pack Number DYNJ0101578F ; 56) MEC EYE PACK, Pack Number DYNJ0101578G ; 57) MEC EYE PACK, Pack Number DYNJ0101578J ; 58) BR EYE PAC, Pack Number DYNJ0101578K ; 59) BR EYE PACK-LF, Pack Number DYNJ0101578L ; 60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ; 61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ; 62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ; 63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ; 64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ; 65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ; 66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ; 67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ; 68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ; 69) CATARACT PACK , Pack Number DYNJ01263G ; 70) CATARACT PACK , Pack Number DYNJ01263I ; 71) CATARACT PACK , Pack Number DYNJ01263J ; 72) CATARACT PACK-LF, Pack Number DYNJ0129784R ; 73) CATARACT PACK-LF, Pack Number DYNJ0129784RH; 74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ; 75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ; 76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ; 77) RETINAL PACK-LF , Pack Number DYNJ0151148B ; 78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ; 79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ; 80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ; 81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ; 82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ; 83) CATARACT PACK-LF, Pack Number DYNJ0159809B ; 84) EYE PACK, Pack Number DYNJ0168810Q ; 85) EYE PBM-LF, Pack Number DYNJ0190619F ; 86) EYE PBM-LF, Pack Num — 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: ACC010647A , Lot Number 23CDC070 ; ACC010647A , Lot Number 23DDA683 ; CDS760053K , Lot Number 22HBP517 ; CDS760053K , Lot Number 22HBS797 ; CDS760053K , Lot Number 22LBS190 ; CDS760053K , Lot Number 23ABC154 ; CDS760053K , Lot Number 23ABM789 ; CDS760053K , Lot Number 23EBB486 ; CDS760053K , Lot Number 23IBP664 ; CDS810010J , Lot Number 19BBU744 ; CDS810010J , Lot Number 19DBL815 ; CDS810010J , Lot Number 19FBH859 ; CDS810010J , Lot Number 19HBO222 ; CDS810010J , Lot Number 19IBG752 ; CDS810010J , Lot Number 20BBT732 ; CDS810010J , Lot Number 20CBY376 ; CDS810010J , Lot Number 20EBA044 ; CDS810010J , Lot Number 20FBF639 ; CDS810010J , Lot Number 21DBT774 ; CDS810010K , Lot Number 21IBI534 ; CDS810010K , Lot Number 21JBM642 ; CDS810010K , Lot Number 21KBT225 ; CDS810010K , Lot Number 21KBY732 ; CDS810010K , Lot Number 21LBJ661 ; CDS810010K , Lot Number 22BBT607 ; CDS810010K , Lot Number 22FBG549 ; CDS810010K , Lot Number 22FBG555 ; CDS810010K , Lot Number 22HBF177 ; CDS810010K , Lot Number 23DBF386 ; CDS810010K , Lot Number 23IBF920 ; CDS810010K , Lot Number 23KBF043 ; CDS810010K , Lot Number 23KBW104 ; CDS810010K , Lot Number 23KBW105 ; CDS810010K , Lot Number 24ABB073 ; CDS810023G, Lot Number 20DBK652; CDS810023G, Lot Number 20DBA257; CDS810023I, Lot Number 21GBP393; CDS810023I, Lot Number 21FBE254; CDS810023I, Lot Number 21BBS695; CDS810023I, Lot Number 20WBE729; CDS810023I, Lot Number 20IBG098; CDS810023I, Lot Number 20GBU914; CDS810023J, Lot Number 23JBI899; CDS810023J, Lot Number 23EBQ471; CDS810023J, Lot Number 23DBI051; CDS810023J, Lot Number 23BBU273; CDS810023J, Lot Number 23BBQ482; CDS810023J, Lot Number 23ABB691; CDS810023J, Lot Number 22LBF785; CDS810023J, Lot Number 22IBG219; CDS810023J, Lot Number 22HBR137; CDS810023J, Lot Number 22GBK847; CDS810023J, Lot Number 22EBS465; CDS810023J, Lot Number 22BBF452; CDS810023J, Lot Number 21LBI699; CDS810023J, Lot Number 21JBQ842; CDS810023K, Lot Number 23KBS455; CDS810032L , Lot Number 19BBP945 ; CDS810032L , Lot Number 19DBE971 ; CDS810032L , Lot Number 19FBJ782 ; CDS810032L , Lot Number 19FBZ139 ; CDS810032L , Lot Number 19IBP875 ; CDS810032L , Lot Number 19VBC448 ; CDS810032L , Lot Number 19KBO504 ; CDS810032L , Lot Number 20BBE593 ; CDS810032L , Lot Number 20DBB545 ; CDS810032L , Lot Number 20FBW326 ; CDS810032L , Lot Number 20HBU689 ; CDS810032L , Lot Number 21ABS929 ; CDS810032L , Lot Number 21BBF822 ; CDS810032M , Lot Number 21GBD880 ; CDS810032M , Lot Number 21GBP404 ; CDS810032M , Lot Number 21KBZ708 ; CDS810032M , Lot Number 22EBB266 ; CDS810032M , Lot Number 22EBC215 ; CDS810032M , Lot Number 22GBF284 ; CDS810032M , Lot Number 21EBC853 ; CDS810032M , Lot Number 21FBG299 ; CDS810032N , Lot Number 22HBI825 ; CDS810032N , Lot Number 22JBC455 ; CDS810032N , Lot Number 22KBM259 ; CDS810032N , Lot Number 23ABJ740 ; CDS810032N , Lot Number 23BBF830 ; CDS810032N , Lot Number 23BBG484 ; CDS810032O , Lot Number 23CBX494 ; CDS810032O , Lot Number 23EBB627 ; CDS810032O , Lot Number 23HBS135 ; 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DYNJ033670. 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-3051-2024 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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