Recall Z-1374-2021 ยท KNW Instrument, Biopsy
Arrow International Inc
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.
| Date | Apr 7, 2021 (initiated Mar 8, 2021) |
| Status | Open, Classified |
| 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 |
| Root cause | Process design |
| Action | Teleflex issued to US consignee notification letter on March 8, 2021 via FedEx 2-day mail. Letter states reason for recall, health risk, and action to take: Action list number 1 Medical facilities 1. We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-Mail address mentioned below. 3. If you do have stock in scope |
| Quantity | 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US and 36 OUS |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113872 | THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE Vidacare Corporation, Mar 8, 2012 |