Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.

FDA Recall Z-1108-2022 · Posted None

Recalling FirmCooperSurgical, Inc.
Recall StatusOpen, Classified
Product CodeMQK
Date Initiated2022-04-01
Product Quantity2,340 (US only)

Reason for Recall

Products in this lot may have compromised barrier seals, introducing a risk to sterility.

Firm 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].

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162833VitriGuardOrigio A/S · 2017-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑