Recall Z-0088-2023 ยท OFF Central Venous Catheter Tray
MEDLINE INDUSTRIES, LP - Northfield
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
| Date | Oct 13, 2022 (initiated Sep 1, 2022) |
| Status | Terminated |
| Reason | Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, instead of a 7cm introducer/sheath, component #137340 - SET INTRO 6.5FX7CM FITS 0.018 |
| Root cause | Under Investigation by firm |
| Action | Medline Industries, LP sent a MEDICAL DEVICE RECALL notice to its consignees on 09/08/2022 by US Mail. The notice identified the product, problem, and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listedon the recall portal. Quarantine all affected product. 2.Please use the link and the information below to complete your response form. Please list thequantity of affected product you have in inventory on the form. Even if you do not have anyaffected product in inventory, please complete and submit the form. |
| Quantity | 1760 kits |
| Distribution | CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.