Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listin
FDA device recall Z-0913-06 · posted 2006-05-31 · Terminated
Recall details
- Recalling firm
- Bard Peripheral Vascular Inc
- Reason for recall
- Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected.
- Action taken
- Recall letters were sent to all consignees (Radiology Department Manager with a copy to the Hospital Administrator) via Federal Express overnight delivery with signature receipt required on May 1, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Bard Peripheral Vascular, Inc (BPV).
- Root cause
- Other
- Status
- Terminated
- Product code
- FCG
- Quantity affected
- 225
- Distribution
- The product was distributed to the following five states: 1) California, 2) Florida 3) New Jersey, 3) Missouri, 4) Texas, 5) Washington. The product was also distributed to Canada and Latin America. N
- Date initiated
- 2006-05-01
- Date posted
- 2006-05-31
- Date terminated
- 2012-04-24
- Location
- Tempe, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COAXIAL BIOPSY NEEDLE (K936194) | Bard Gynecology and Radiology | 1994-03-22 |
| BIP-COAX-SYSTEM (K915801) | Uni-Quatro Industries Canada, Inc. | 1994-03-11 |