Recall Z-1471-2022 ยท OFF Central Venous Catheter Tray
MEDLINE INDUSTRIES, LP - SPT
Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number DYNJ905860A
| Date | Jun 6, 2022 |
| Status | Open, Classified |
| Reason | Kits contain leaking bottles of isopropyl alcohol |
| Root cause | Under Investigation by firm |
| Action | The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations. |
| Quantity | 288 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.