FDAClass IIApril 20, 2016

Bard TruGuide Disposable Coaxial Biopsy Needle Product recall

Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle…

Why was Bard TruGuide Disposable Coaxial Biopsy Needle Product recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle…
Recalling firm
Bard Peripheral Vascular Inc
Quantity
2320 units
Distribution
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.
Recall date
April 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls