Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.
FDA device recall Z-0183-2009 · posted 2008-10-22 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- 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.
- 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
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 225
- Distribution
- Nationwide Distribution --- including states of AL, AR, CA, FL, KY, MA, NY, OH, SC, TN, TX, VA, and WA.
- Date initiated
- 2008-09-12
- Date posted
- 2008-10-22
- Date terminated
- 2012-09-19
- Location
- Tempe, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 (K062832) | C.R. Bard, Inc. | 2006-10-20 |