Z-0183-2009
Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140
Bard Peripheral Vascular Inc / initiated 2008-09-12 / Terminated / root cause: design
Bard Peripheral Vascular Inc began a recall of Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140 on . The reason FDA records is "Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb wheels from these lots may fracture when fired using the prime/pierce option". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0183-2009
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.
- Product code
- KNW Instrument, Biopsy
- 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.
- Root cause tag
- design
- FDA 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 Consignment Recall Number. fax the form to BVP at 1-800-440-5376
- Quantity in commerce
- 225
- Distribution
- Nationwide Distribution --- including states of AL, AR, CA, FL, KY, MA, NY, OH, SC, TN, TX, VA, and WA.
- Product codes and lots
- Lots 431PI148 (VB10118) 43IPI013(VB10140) and 43IPI014 (VB10140) with expiry date September 2008
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