Reported Aug 24, 2016 · Terminated

Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial…

Bard Peripheral Vascular Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St · Tempe, AZ · 85281-2438

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot NumberREZK0479
Amount recalled
1250 units

Where it was sold

Why it was recalled

May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 17, 2016 · Data as of Sep 19, 6:46 PM UTC

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