Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. M...
Reason for Recall / Hazard
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Product Description & Identification
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.
Affected Products
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ24250G; 5. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333D; 6. CATH LAB PACK-LF, Medline Kit Number/SKU DYNJ38333F; 7. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779G; 8. CATH LAB ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ50779I; 9. CLOT RETRIEVAL PACK, Medline Kit Number/SKU DYNJ56140C; 10. TAVR PACK NO SYR, Medline Kit Number/SKU DYNJ62310C; 11. TAVR PACK, Medline Kit Number/SKU DYNJ62310D; 12. TAVR PACK, Medline Kit Number/SKU DYNJ62310F; 13. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911; 14. DIAGNOSTIC 2 PACK, Medline Kit Number/SKU DYNJ81911A; 15. CATH PACK, Medline Kit Number/SKU DYNJT6544; 16. LHK, Medline Kit Number/SKU NAM0015; 17. SLU LHK, Medline Kit Number/SKU SAMPC0706.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98735 |
| Address 1 | 3 Lakes Dr |
| Code info | Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102; Medline Kit Number/SKU 60010508: UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Nu... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 21119 kits |
| Reason for recall | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260324 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260508 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass I
- DistributionUS (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.