VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
- Company
- Coopersurgical, Inc.
- Recall Initiated
- April 1, 2022
- Recall Number
- Z-1108-2022
- Quantity
- 2,340 (US only)
- Firm Location
- Trumbull, CT
Reason for Recall
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
Distribution
Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
Lot / Code Info
GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796 Lot 264453
Root Cause
Process control
Action Taken
On April 1, 2022, the firm distributed URGENT Medical Device Safety Notices to affected customers. Customers were informed of the potential breach to the sterile barrier of the affected lot. Customers should discontinue use of the affected lot and quarantine the product for return to CooperSurgical. If you have additional questions, please contact a CooperSurgical Product Surveillance representative at 203.601.5200 Ext. 3300 or email the firm at recall@coopersurgical.com.