Recall Z-0405-2022 ยท PZG Surgical Eye Tray
Beaver Visitec International, Inc.
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
| Date | Nov 17, 2021 |
| Status | Open, Classified |
| Reason | Kit packaging may have small holes compromising product sterility |
| Root cause | Packaging change control |
| Action | Beaver Visitec issued Urgent Medical Device Recall notification dated 11/17/21 to the first level consignee. Letter states reason for recall, health risk and action to take: PLEASE perform the following actions: 1. Immediately examine your inventory and quarantine product from these lots that are subject to 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. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Comp |
| Quantity | 920 units |
| Distribution | CA, CO, LA, MA, MD, ND, PA, TN, UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.