Recall Z-2089-2019 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Wilson-Cook Medical Inc.
Acuject Variable Injection Needle
| Date | Jun 14, 2019 |
| Status | Terminated |
| Reason | Potential for occluded injection needles. |
| Root cause | Employee error |
| Action | Wilson-Cook Medical notified their customer on about 06/14/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. The letter instructed customers to examine inventory for affected devices, quarantine any affected devices, notify customers if the product has been further distributed, and return affected devices to Cook China as soon as possible. The customer was also instructed to complete the provided Recall Return Response form and send it to Cook China. |
| Quantity | 24 |
| Distribution | Distributed to China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941305 | WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLE Wilson-Cook Medical, Inc., Jun 2, 1994 |