—#45532

Product

Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listing Number E148687. The Bard TruGuide Coaxial Biopsy Needle is a three-part device consisting of an outer cannula with an attached female luer lock hub, and inner stylet with an attached male luer lock hub, and a flexible slip rink depth stop.

FDA product code: FCG — Biopsy Needle
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K915801, K936194
Affected lot / code info: Lot # REP JO196

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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).

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: 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. Note: units distributed to Latin America remained in Bard''s distribution system and have been returned.

Timeline

Recall initiated: 2006-05-01
Posted by FDA: 2006-05-31
Terminated: 2012-04-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45532. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.