Bard Peripheral Vascular Inc: Medical Device Recall in 2016 - (Recall #: Z-1396-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 4, 2016

Date Posted: April 20, 2016

Recall Number: Z-1396-2016

Event ID: 73249

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2320 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated