Recall Z-2547-2016 ยท FCG Biopsy Needle
Bard Peripheral Vascular Inc
Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
| Date | Aug 16, 2016 (initiated Jul 6, 2016) |
| Status | Terminated |
| Reason | May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. |
| Root cause | Packaging |
| Action | Bard Peripheral Vascular (BVP) sent an Urgent Medical Device Recall Notification letter dated July 6, 2016 to all affected customers via FedEx with proof of delivery notification.. The letter identified the product, the problem, and the action to be taken by the customer. The notification provided customers the following instructions: 1. Do not use or further distribute any affected product. 2. Check all inventory locations within your institution for affected product code I lot number combination listed in the recall notice. If you have further distributed any of the product code I |
| Quantity | 1250 units |
| Distribution | Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO. Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K936194 | COAXIAL BIOPSY NEEDLE Bard Gynecology and Radiology, Mar 22, 1994 |