Z-1108-2022 Class II Ongoing
FDA device recall Z-1108-2022 was initiated by CooperSurgical, Inc. on Apr 1, 2022 and is designated Class II. Reason for recall: Products in this lot may have compromised barrier seals, introducing a risk to sterility. The recall status is ongoing. Affected quantity: 2,340 (US only).
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- Apr 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,340 (US only)
Product Description
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Reason for Recall
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
Distribution Pattern
Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
Code Information
GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796 Lot 264453
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1108-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026