Recall Z-0265-2023 ยท OFF Central Venous Catheter Tray
Medical Action Industries, Inc. 306
B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
| Date | Nov 18, 2022 (initiated Sep 15, 2022) |
| Status | Terminated |
| Reason | The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024. |
| Root cause | Under Investigation by firm |
| Action | Owens & Minor/Medical Action INDUSTRIES, INC. issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its sole consignee on 09/23/2022 by email. The notices explained the issue and requested they take the following actions: "Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be appl |
| Quantity | 240 cases of 20 units |
| Distribution | US Nationwide distribution in the state of Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.