Z-1108-2022Class II

VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device...

Name: Z-1108-2022 VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device...
Creator: CooperSurgical, Inc.
Published: 2022-04-01
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2022-04-01 / Open, Classified / root cause: manufacturing process

FDA source

CooperSurgical, Inc. began a recall of VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap on 2022-04-01. FDA classified it as Class II and gives the reason as "Products in this lot may have compromised barrier seals, introducing a risk to sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1108-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-01
Posted: 2022-05-17
Recalling firm: CooperSurgical, Inc.
Product: VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Product code: MQK Labware, Assisted Reproduction
Reason for recall: Products in this lot may have compromised barrier seals, introducing a risk to sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected].
Quantity in commerce: 2,340 (US only)
Distribution: Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
Product codes and lots: GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796 Lot 264453

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1108-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1108-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-17

Product code MQK

K162833Class IIVitriGuardOrigio A/S / cleared 2017-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)