Reported Apr 15, 2020 · Terminated
Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X -…
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?
- Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP
- Sterile - Product CodeDJ4011X -
- Product UsageThe device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique
- Lot codes and dates
- Lot Numbers0001303256 and 0001303257
- Amount recalled
- 8,170 units (US: 420 and OUS: 7,750)
Where it was sold
Why it was recalled
Sterility compromised due to packaging pouches that may not be sealed properly
This product could cause temporary or reversible health problems — stop using it.
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