Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
- Recall Initiated
- November 17, 2021
- Recall Number
- Z-0410-2022
- Quantity
- 1170 units
- Firm Location
- City Point Waltham, MA
Reason for Recall
Kit packaging may have small holes compromising product sterility
Distribution
CA, CO, LA, MA, MD, ND, PA, TN, UT
Lot / Code Info
Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371
Root Cause
Packaging change control
Action Taken
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. Complete the enclosed Business Reply Form (BRF) and indicate whether you have affected product to return. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. Return the completed BRF to BVI by one of these methods: " Fax to 866-912-8416 " Email the attached to beavervisitec3570@sedgwick.com 5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event 3570 If you have questions regarding the return procedure, please contact Stericycle Inc. at 866-625-5325 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time).