Recall record at a glance
| Official record | Z-1436-2025 |
|---|---|
| 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 | 1939 units |
| Location | Northfield, IL, United States |
Official product description
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ42873; 7) ANGIOGRAPHY PACK, Pack Number DYNJ57498; 8) ANGIOGRAPHY PACK, Pack Number DYNJ52167A; 9) ANGIOGRAPHY PACK, Pack Number DYNJV0173I; 10) ANGIOGRAPHY TRAY-LF, Pack Number DYNJ58722A; 11) CATH LAB PACK, Pack Number DYNJ42912F; 12) CATH LAB PK, Pack Number DYNJ35643B; 13) CATH PACK-LF, Pack Number DYNJ0367643Q; 14) CRMS ANGIO PACK-LF, Pack Number PHS616026002A; 15) DEPAUL ANGIO CATH PACK, Pack Number DYNJ24542L
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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