Reported Oct 11, 2023 · Ongoing
Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
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 Marquee Disposable Core Biopsy Instrument Kit
- REFMQK2016
- Lot codes and dates
- UDI-DI00801741097393
- Lot0001480774
- Exp07/28/2025
- Amount recalled
- 1,545
Where it was sold
Why it was recalled
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.
This product could cause temporary or reversible health problems — stop using it.
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