Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.
FDA Recall Z-0183-2009 · Posted 2008-10-22
Advertisement
Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeKNW
Date Initiated2008-09-12
Date Terminated2012-09-19
Product Quantity225
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.
Firm 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
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution --- including states of AL, AR, CA, FL, KY, MA, NY, OH, SC, TN, TX, VA, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement