Reported May 17, 2023 · Ongoing
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
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 Bldg 1 · Tempe, AZ · 85281-2438
Is this the product you have?
- Bard Mission
- Disposable Core Biopsy Instrument Kit
REF: 2010MSK20G x 10CM
- REF
2016MSK20G x 16CM
- Lot codes and dates
- REF/UDI-DI/Lot (Expiration Date)2010MSK/00801741097089/0001445946(11/28/2024), 2016MSK/00801741097096/1458844(02/28/2025)
- Amount recalled
- 4,120
Where it was sold
Why it was recalled
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
This product could cause temporary or reversible health problems — stop using it.
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