Recall Z-0782-2023 ยท HNN Knife, Ophthalmic
Beaver Visitec International, Inc.
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
| Date | Jan 4, 2023 (initiated Nov 30, 2022) |
| Status | Open, Classified |
| Reason | Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection |
| Root cause | Under Investigation by firm |
| Action | Beaver Visitec (BVI) issued Urgent Medical Device Recall Letter (FA-22-006) on 11/30/22 via certified mail to Distributors/Customers. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from the lot that is subject to this recall. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. Use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Respon |
| Quantity | 599 units (US): 410 units; 189 kits |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.