Recall Z-0737-2021 ยท EFQ Gauze/Sponge, Internal
ROi CPS LLC
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504. 5) Regard, LAP CHOLE, Item 800003011, Lot # 82497. 6) Regard, SHOULDER ARTHRO, Item 800075010, Lot # 82490. 7) Regard, CERVICA
| Date | Nov 9, 2020 |
| Status | Terminated |
| Reason | Gauze sponges contained in custom kits may be flaking or fraying. |
| Root cause | Component design/selection |
| Action | ROi CPS, LLC on 11/17/2020 sent a notice to its customers with the following instructions: Actions to be taken by customers: 1. CHECK: Please review your inventory to determine if the ROi Custom Procedure Kit manufacturer item numbers and lot numbers listed in the above table are in your inventory. 2. REPLY: If the affected kits are identified, please notify ROi CPS, LLC of the quantity on hand by completing the reply form included in this notice. Please email this form to lacy.stewart@roiscs .com . a. If you do not have inventory, please return the form indicating "O" affected inventory a |
| Quantity | 17,700 total kits |
| Distribution | US Domestic Distribution Only: MO, NC, LA and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.