Z-1108-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- April 1, 2022
- Termination Date
- N/A
- 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