Z-1200-2023 Class II Ongoing
FDA device recall Z-1200-2023 was initiated by Beaver Visitec International, Inc. on Dec 20, 2022 and is designated Class II. Reason for recall: Device packaging may contain open seals, compromising product sterility. The recall status is ongoing. Affected quantity: 4640 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 8, 2023
- Initiation Date
- Dec 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4640 units in total
Product Description
CustomEyes kits
Reason for Recall
Device packaging may contain open seals, compromising product sterility.
Distribution Pattern
US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa
Code Information
Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1200-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026