Recall Z-0183-2009
Bard Peripheral Vascular Inc · initiated September 12, 2008
Product
Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.
Codes / lots: Lots 431PI148 (VB10118) 43IPI013(VB10140) and 43IPI014 (VB10140) with expiry date September 2008
Reason for recall
Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb wheels from these lots may fracture when fired using the prime/pierce option.
FDA-determined cause: Device Design
Action taken
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 Consignment Recall Number. fax the form to BVP at 1-800-440-5376
Details
- Recall number
- Z-0183-2009
- Initiated
- September 12, 2008
- Posted by FDA
- October 22, 2008
- Terminated
- September 19, 2012
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 225
- Distribution
- Nationwide Distribution --- including states of AL, AR, CA, FL, KY, MA, NY, OH, SC, TN, TX, VA, and WA.
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ