Medline procedure kits labeled as: 1) AOP/BASIC EYE recall
Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE…
Why was Medline procedure kits labeled as: 1) AOP/BASIC EYE 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 5,132 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- April 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)