VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed o
Summary
The FDA issued a Class II for VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cr by CooperSurgical, Inc.. Reason: Products in this lot may have compromised barrier seals, introducing a risk to sterility..
Details
Source
Device Recall
External ID
Z-1108-2022
Action Date
2022-05-25
Status
Ongoing
Category
device
Product Description
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Lot/Code Info: GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796 Lot 264453
Quantity Affected: 2,340 (US only)
Reason for Recall
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
Distribution
Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-01
Company
Trumbull, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CooperSurgical, Inc. has 38 FDA actions in our database, including 35 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CooperSurgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CooperSurgical, Inc. have FDA actions?
CooperSurgical, Inc. has 38 FDA actions in our database, including 35 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1108-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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