Recall Z-1396-2016 ยท FCG Biopsy Needle
Bard Peripheral Vascular Inc
Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: 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 | Feb 4, 2016 |
| Status | Terminated |
| Reason | Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm sent a customer notification letter on 02/04/15 to each of the US consignees via FedEx with proof of delivery notification. The firm's notification letter provided the following instructions for completing the required actions: 1. Do not further use the affected product. 2. Check all inventory locations within the institution for affected product code/lot number combination listed in the recall notice. If further distributed any of the product code/lot numbers immediately contact that location, advise them of the recall, forward the instructions and have them return the affected pr |
| Quantity | 2320 units |
| Distribution | U.S. distribution to the following; SC, CO, MT, PA, MA, TX, MI, VA OH, CA, GA, WA, MO, KS, TN, IA, FL, NV, PR. Foreign distribution to the following; Canada, Austria, Brazil, China, Cyprus, Holland, France, Spain, Netherlands, Norway, Portugal, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K936194 | COAXIAL BIOPSY NEEDLE Bard Gynecology and Radiology, Mar 22, 1994 |