Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 recall
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…
Why was Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers US: 39647326 39647327 39647328 40422734 40422735 Lot Number: 40808740 (EU) EXPANDED RECALL: 5/4/21 Lot Numbers: 38347967 40422740
- 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…
- Recalling firm
- Arrow International Inc
- Quantity
- 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS
- Distribution
- US Nationwide distribution.
- Recall date
- April 14, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)