Recall Z-1255-2022 ยท LRO General Surgery Tray
ROi CPS LLC
regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
| Date | May 3, 2022 |
| Status | Terminated |
| Reason | Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled. |
| Root cause | Other |
| Action | ROI notified the sole consignee with a MEDICAL DEVICE RECALL NOTICE by email on 05/03/2022. The letter explained the problem and requested the following actions: "Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the item/lot number listed in the above table are in your inventory. 2. HOLD: Quarantine all affected kits in your inventory and do not further distribute or use. 3. REPLY: Complete the recall reply form attached to this notice and return to lacy.stewart@roiscsc.com. a. If you do not have inventory, please return the form indicating "0" affecte |
| Quantity | 24 kits |
| Distribution | FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.