Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pack Number DYNJ56056B; 5) CATARACT PACK, Pack Number DYNJ56553B; 6) CATARACT PACK, Pack Number DYNJ0417156G; 7) CATARACT PACK, Pack Number DYNJ60411A; 8) CATARACT PACK, Pack Number DYNJ52649F; 9) CATARACT PACK - 30843, Pack Number DYNJVB1076B; 10) CATARACT PACK-LF, Pack Number DYNJ0317858M; 11) CATARACT-LF, Pack Number DYNJ40081F; 12) ENT PACK, Pack Number DYNJ38916B; 13) EYE CATARACT PK, Pack Number DYNJ46557K; 14) EYE CATARACT PK, Pack Number DYNJ46557L; 15) EYE PACK, Pack Number DYNJ48800C; 16) EYE PACK, Pack Number DYNJ38494G; 17) EYE PACK, Pack Number DYNJ21134A; 18) EYE PACK 1, Pack Number DYNJHTEY01; 19) EYE PACK II-LF, Pack Number DYNJ50237A; 20) EYE PBM-LF, Pack Number DYNJ0190619G; 21) MZ GENERAL EYE PACK, Pack Number DYNJ66623A; 22) OCULAR PLASTICS, Pack Number DYNJ82032; 23) OPHTHALMOLOGY PACK, Pack Number DYNJ52885D; 24) OPHTHALMOLOGY PACK, Pack Number DYNJ52885F; 25) PK, OPHTH-RETINA, Pack Number DYNJ45046A; 26) PLASTIC PACK, Pack Number DYNJ82060A; 27) RETINAL DSC, Pack Number DYNJ68940A; 28) SMSC- EYE PACK HOSP&CLINIC-LF, Pack Number DYNJ0780084F; 29) STRABISMUS PACK-LF, Pack Number DYNJ0789014K; 30) RETINAL PACK, Pack Number LYN030REFCA; 31) EYE PACK WHITEWATER SC, Pack Number VAL038EPWSB
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: 1) Pack Number DYNJ0589795V: UDI/DI 10193489826722 (each) 40193489826723 (case), Lot Number 23LMF853A; 2) Pack Number DYNJ39921B: UDI/DI 10195327176365 (each) 40195327176366 (case), Lot Number 24AMI654A; 3) Pack Number DYNJ45662C: UDI/DI 10193489556636 (each) 40193489556637 (case), Lot Number 20EBE340A; 4) Pack Number DYNJ56056B: UDI/DI 10193489635348 (each) 40193489635349 (case), Lot Number 20JKA823A; 5) Pack Number DYNJ56553B: UDI/DI 10193489761962 (each) 40193489761963 (case), Lot Number 21IMG706A; 6) Pack Number DYNJ0417156G: UDI/DI 10889942067428 (each) 40889942067429 (case), Lot Number 22IMG784A; 7) Pack Number DYNJ60411A: UDI/DI 10195327221393 (each) 40195327221394 (case), Lot Number 22IMG811A; 8) Pack Number DYNJ52649F: UDI/DI 10195327357313 (each) 40195327357314 (case), Lot Number 23HME435A; 9) Pack Number DYNJVB1076B: UDI/DI 10195327062736 (each) 40195327062737 (case), Lot Number 23CLA046A; 10) Pack Number DYNJ0317858M: UDI/DI 10889942399789 (each) 40889942399780 (case), Lot Number 22IMD667A; 11) Pack Number DYNJ40081F: UDI/DI 10195327068370 (each) 40195327068371 (case), Lot Number 23IMC700A; 12) Pack Number DYNJ38916B: UDI/DI 10193489969863 (each) 40193489969864 (case), Lot Number 23HMC484A; 13) Pack Number DYNJ46557K: UDI/DI 10193489987225 (each) 40193489987226 (case), Lot Number 23FMF487A; 14) Pack Number DYNJ46557L: UDI/DI 10195327466879 (each) 40195327466870 (case), Lot Number 23LMF146A; 15) Pack Number DYNJ48800C: UDI/DI 10193489602173 (each) 40193489602174 (case), Lot Number 22IME600A; 16) Pack Number DYNJ38494G: UDI/DI 10193489404890 (each) 40193489404891 (case), Lot Number 22IMF477A; 17) Pack Number DYNJ21134A: UDI/DI 10080196818327 (each) 40080196818328 (case), Lot Number 23GMC030A; 18) Pack Number DYNJHTEY01: UDI/DI 10888277078758 (each) 40888277078759 (case), Lot Number 23HBT532A; 19) Pack Number DYNJ50237A: UDI/DI 10195327013967 (each) 40195327013968 (case), Lot Number 21KBW890A; 20) Pack Number DYNJ0190619G: UDI/DI 10193489442588 (each) 40193489442589 (case), Lot Number 21IMH127A; 21) Pack Number DYNJ66623A: UDI/DI 10195327001605 (each) 40195327001606 (case), Lot Number 22IMG395A; 22) Pack Number DYNJ82032: UDI/DI 10195327162689 (each) 40195327162680 (case), Lot Number 22JBO961A; 23) Pack Number DYNJ52885D: UDI/DI 10195327002077 (each) 40195327002078 (case), Lot Number 21JMH611A; 24) Pack Number DYNJ52885F: UDI/DI 10195327118877 (each) 40195327118878 (case), Lot Number 22IMH094A; 25) Pack Number DYNJ45046A: UDI/DI 10193489791112 (each) 40193489791113 (case), Lot Number 21FME768A; 26) Pack Number DYNJ82060A: UDI/DI 10195327370145 (each) 40195327370146 (case), Lot Number 23LMF289A; 27) Pack Number DYNJ68940A: UDI/DI 10195327326524 (each) 40195327326525 (case), Lot Number 23EMD688A; 28) Pack Number DYNJ0780084F: UDI/DI 10889942089598 (each) 40889942089599 (case), Lot Number 21AMA688A; 29) Pack Number DYNJ0789014K: UDI/DI 10193489954333 (each) 40193489954334 (case), Lot Number 21LMF629A; 30) Pack Number LYN030REFCA: UDI/DI 10195327152383 (each) 40195327152384 (case), Lot Number 22GBI949A; 31) Pack Number VAL038EPWSB: UDI/DI 10193489209976 (each) 40193489209977 (case), Lot Number 23GBE924A