Recall Z-0632-2024 ยท HNN Knife, Ophthalmic
Beaver Visitec International, Inc.
Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
| Date | Jan 4, 2024 (initiated Aug 25, 2023) |
| Status | Open, Classified |
| Reason | One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Field Safety Notice dated 8/25/23 was sent to customers. Actions Required by You Our records show you received one or more affected product. You can recognize the affected product by determining whether the lot number printed on the device label is one of the affected lots. PLEASE perform the following actions: 1. Immediately examine your inventory and determine if the blades on the knives are bevel-up as intended or bevel down. Only destroy the knives in your inventory that have the incorrect bevel orientation (bevel down). If you have further distributed this product, please noti |
| Quantity | 1980 units |
| Distribution | International distribution to the countries of Belgium, China, France, Germany, Greece, Italy, Jordan, Lithuania, Netherlands, Oman, Poland, Spain, Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.