FDA Device recall Z-1108-2022
VITRIGUARD, CARRIER, CLEAR
- FDA Device
- Class II
- ongoing
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of VITRIGUARD, CARRIER, CLEAR by Coopersurgical, citing products in this lot may have compromised barrier seals, introducing a risk to sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1108-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-01 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopersurgical |
| Distribution | AZ, CA, FL, IL, MI, MO, NY, OR, TX, WV |
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.
Identifiers
| code_info | GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796 Lot 264453 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1108-2022%22
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