FDA recall Z-1108-2022

CooperSurgical, Inc. · Class II · device

Product

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

Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.

Key facts

Status
Ongoing
Initiation date
2022-04-01
Report date
2022-05-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1108-2022