Skip to content
Recall Observatory FDA recall evidence

Device product

Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Z-1396-2016

February 04, 2016

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 73249
Status
Terminated
Classification
Class II
Quantity
2320 units
Official record key
device-enforcement:Z-1396-2016

Official wording

Reason: Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial.

Code information: Part Number: C2016B Lot Numbers: REWL0924, REXA1695, REXB1529, REXC1632

Distribution pattern: U.S. distribution to the following; SC, CO, MT, PA, MA, TX, MI, VA OH, CA, GA, WA, MO, KS, TN, IA, FL, NV, PR. Foreign distribution to the following; Canada, Austria, Brazil, China, Cyprus, Holland, France, Spain, Netherlands, Norway, Portugal, UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial.