Recall Z-1674-2017 ยท LRO General Surgery Tray
Resource Optimization & Innovation Llc
Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
| Date | Jan 9, 2017 |
| Status | Terminated |
| Reason | Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field. |
| Root cause | Nonconforming Material/Component |
| Action | ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793. |
| Quantity | 210 kits |
| Distribution | US Distribution to LA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.