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.
Reported: April 14, 2021 Initiated: March 8, 2021 #Z-1374-2021
Product Description
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.
Reason for Recall
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
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS
- Distribution
- US Nationwide distribution.
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Arrow International Inc. Units affected: 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1374-2021.
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