—#212691

Product

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

FDA product code: OJK — Eye Tray
Device class: Class 2
Medical specialty: Ophthalmic
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. This is an expansion of RES 94583

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated: 2025-02-11
Posted by FDA: 2025-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212691. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.