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 Recall Z-0913-06 · Posted 2006-05-31
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Recalling FirmBard Peripheral Vascular Inc
Recall StatusTerminated
Product CodeFCG
Date Initiated2006-05-01
Date Terminated2012-04-24
Product Quantity225
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.
Firm Action
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
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.
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.
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