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Arrow International Inc recalls Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Pr
Recalled April 14, 2021 · FDA recall Z-1374-2021 · Arrow International
Hazard
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 · FDA Class II
Units
3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS
Sold at
US Nationwide distribution.
Description
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
Product
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.
Manufacturer(s)
Arrow International Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →