Z-1396-2016 Class II Terminated
FDA device recall Z-1396-2016 was initiated by Bard Peripheral Vascular Inc on Feb 4, 2016 and is designated Class II. 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… The recall status is terminated (terminated Aug 3, 2016). Affected quantity: 2320 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 20, 2016
- Initiation Date
- Feb 4, 2016
- Termination Date
- Aug 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2320 units
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.
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.
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.
Code Information
Part Number: C2016B Lot Numbers: REWL0924, REXA1695, REXB1529, REXC1632
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1396-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026