Z-0405-2022 Class II Ongoing
FDA device recall Z-0405-2022 was initiated by Beaver Visitec International, Inc. on November 17, 2021 and is designated Class II. Reason for recall: Kit packaging may have small holes compromising product sterility The recall status is ongoing. Affected quantity: 920 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 29, 2021
- Initiation Date
- November 17, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 920 units
Product Description
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
Reason for Recall
Kit packaging may have small holes compromising product sterility
Distribution Pattern
CA, CO, LA, MA, MD, ND, PA, TN, UT
Code Information
Lot Numbers: 3309015, 3347920, 3351630, 3356836, 3360219, 3364419