Recall record at a glance
| Official record | Z-1451-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Apr 2, 2025 |
| Recall initiation date | Feb 11, 2025 |
| Quantity | 5,132 units |
| Location | Northfield, IL, United States |
Official product description
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
Why the product 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.
Distribution information
Worldwide distribution - US Nationwide and the country of Canada.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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