Recall archive / FDA device enforcement
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed o... — FDA record Z-1108-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
- Reason
- Products in this lot may have compromised barrier seals, introducing a risk to sterility.
- Classification
- Class II
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 2,340 (US only)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1108-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796 Lot 264453 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 25, 2022
- Recall initiation date
- Apr 1, 2022
- Center classification date
- May 17, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.