Recall Z-1108-2022— CooperSurgical, Inc.

Name: FDA recall Z-1108-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-01

Class II · Ongoing

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2022-04-01. It names one FDA 510(k) clearance: K162833. 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..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-04-01
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K162833 — VitriGuardOrigio A/S·cleared 2017-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.