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U.S. Department of Health and Human Services

Class 3 Device Recall Bard Vacora Biopsy Vacuum Assisted Biopsy Probe

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 Class 3 Device Recall Bard Vacora Biopsy Vacuum Assisted Biopsy Probesee related information
Date Initiated by FirmSeptember 12, 2008
Date PostedOctober 22, 2008
Recall Status1 Terminated 3 on September 19, 2012
Recall NumberZ-0183-2009
Recall Event ID 49540
510(K)NumberK062832 
Product Classification Biopsy Instrument - Product Code KNW
ProductBard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.
Code Information Lots 431PI148 (VB10118) 43IPI013(VB10140) and 43IPI014 (VB10140) with expiry date September 2008
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
Manufacturer 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 2		Device Design
ActionProduct 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 Commerce225
DistributionNationwide Distribution --- including states of AL, AR, CA, FL, KY, MA, NY, OH, SC, TN, TX, VA, and WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KNW
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