Recall Z-0183-2009 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.
| Date | Oct 22, 2008 (initiated Sep 12, 2008) |
| Status | Terminated |
| Reason | Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb wheels from these lots may fracture when fired using the prime/pierce option. |
| Root cause | Device Design |
| Action | Product Recall Notification Letter sent dated September 11, 2008 Attention: Risk Managers "All VB10118 and VB10140 catalog numbers with expiry dates prior to September 2008 are now beyond their expiration date. In accordance with accepted medical practice, they should have been discarded and not used. Do not use or further distribute any affected products. Once the product affected by the recall has been removed from your inventory; fill out the recall & effectiveness check form, call Silvia Carrillo at 1-800-321-4254 ext 2727 to issue your with either a Return Authorization Number or Consig |
| Quantity | 225 |
| Distribution | Nationwide Distribution --- including states of AL, AR, CA, FL, KY, MA, NY, OH, SC, TN, TX, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062832 | VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 C.R. Bard, Inc., Oct 20, 2006 |