Arrow International Inc Recall 87499
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.
Arrow International Inc Recall 87499 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1374-2021 |
| Event ID | 87499 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS |
| Recall Reason | 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 |
| Device Classification | 20210414 |
| Device Code Info | Lot Numbers US: 39647326 39647327 39647328 40422734 40422735 Lot Number: 40808740 (EU) EXPANDED RECALL: 5/4/21 Lot Numbers: 38347967 40422740 |
| Center Classification Date | 20210407 |
| Recall Initiation Date | 20210308 |
| Recalling Firm | Arrow International Inc |
| Initial Notification | Letter |
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