Recall Z-0943-2015 ยท OGJ Nerve Block Tray
Centurion Medical Products Corporation
Nerve Block Tray (Nerve Block convenience kit)
| Date | Jan 8, 2015 (initiated Oct 23, 2014) |
| Status | Terminated |
| Reason | According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper. |
| Root cause | Nonconforming Material/Component |
| Action | Centurion sent an Urgent Product Recall Notice dated October 23, 2014, to al affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and remove all affected inventory that may be in their possession and to forward a copy of thie noctice to any cusotmers to whom the affected product may have been further distributed. Customers were asked to complete the enclosed accountability record whether not they have the product and fax to 517-546-3356. Customers with questions were instructed to call 517-546 |
| Quantity | 480 kits |
| Distribution | Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.