Vitriguard, Carrier, Clear recallZ-1108-2022 · CooperSurgical, Inc. · initiated Apr 1, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
FDA root cause category: Process control
What the company is doing
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].
Recall details
- Recall number
- Z-1108-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 1, 2022
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 2,340 (US only)
- Product code
- MQK
- FDA submissions
- K162833
- Distribution
- Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
Product description
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Code information (models, lots, serial numbers)
GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796 Lot 264453
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VitriGuard 43782001Origio A/S · Labware, Assisted Reproduction1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page