Recall Z-1294-2024 ยท HMX Cannula, Ophthalmic
Beaver Visitec International, Inc.
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
| Date | Mar 14, 2024 (initiated Feb 2, 2024) |
| Status | Open, Classified |
| Reason | Pack and pouch label is missing the manufacturing and expiration date. |
| Root cause | Under Investigation by firm |
| Action | Beaver Visitec International issued URGENT FIELD SAFETY NOTICE- FA-24-001 letter on 1/19/24. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from these lots that are subject to this FSN. 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. You are encouraged to use a copy of this Field Safety Notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) |
| Quantity | 3,000 units (US and OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.