Z-2547-2016 Class II Terminated
FDA device recall Z-2547-2016 was initiated by Bard Peripheral Vascular Inc on Jul 6, 2016 and is designated Class II. Reason for recall: May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. The recall status is terminated (terminated Nov 17, 2016). Affected quantity: 1250 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 24, 2016
- Initiation Date
- Jul 6, 2016
- Termination Date
- Nov 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1250 units
Product Description
Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B 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
May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.
Distribution Pattern
Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO. Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.
Code Information
Lot Number: REZK0479
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2547-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026