Device product
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Z-1108-2022
Product summary
- Event
- Event 90042
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,340 (US only)
- Official record key
device-enforcement:Z-1108-2022
Official wording
Reason: Products in this lot may have compromised barrier seals, introducing a risk to sterility.
Code information: GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796 Lot 264453
Distribution pattern: Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
Derived failure modes
-
Unknown
Products in this lot may have compromised barrier seals, introducing a risk to sterility.