Z-0408-2022 Class II Ongoing
FDA device recall Z-0408-2022 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: 30 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
- 30 units
Product Description
Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1
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: 3289074