Reported Apr 14, 2021 · Ongoing
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US)…
Arrow International 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: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
- Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy
- Product Code9464-VC-006 (US)
- Product Code9464-EU-001 (sold in
- European Regions only) - Product Usageintended for bone biopsy of the vertebral body and bone lesions
- Lot codes and dates
- Lot Numbers US39647326 39647327 39647328 40422734 40422735
- Lot Number40808740 (EU)
- EXPANDED RECALL5/4/21
- Lot Numbers38347967 40422740
- Amount recalled
- 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS
Where it was sold
- Nationwide
Why it was recalled
Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure
This product could cause temporary or reversible health problems — stop using it.
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