Recall Z-0315-2024 ยท OEZ Cardiovascular Procedure Kit
ROi CPS LLC
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
| Date | Nov 16, 2023 (initiated Sep 21, 2023) |
| Status | Open, Classified |
| Reason | Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains. |
| Root cause | Other |
| Action | ROi CPS, LLC issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 09/29/2023 via email. The email attached the notice and the notice received from Getinge. The notice explained the issue, the potential risks, and requested the distributor notify their customer. End user was directed to post the Getinge notice in area where the affect kits were used. An updated notice was sent on 10/13/2023 via email with the corrected item numbers with the same instructions. |
| Quantity | 134 units |
| Distribution | MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.