FDA Device recall Z-1396-2016
Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guid…
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guid… by Bard Peripheral Vascular, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1396-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-04 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | CA, CO, FL, GA, IA, KS, MA, MI, MO, MT, NV, OH, PA, PR, SC, TN, TX, VA, WA |
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.
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.
Identifiers
| code_info | Part Number: C2016B Lot Numbers: REWL0924, REXA1695, REXB1529, REXC1632 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1396-2016%22
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