Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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