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U.S. Department of Health and Human Services

Class 2 Device Recall VitriGuard

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 Class 2 Device Recall VitriGuardsee related information
Date Initiated by FirmApril 01, 2022
Create DateMay 17, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1108-2022
Recall Event ID 90042
510(K)NumberK162833 
Product Classification Labware, assisted reproduction - Product Code MQK
ProductVITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Code Information GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796  Lot 264453
FEI Number 1216677
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactCustomer Service
203-601-9818
Manufacturer Reason
for Recall		Products in this lot may have compromised barrier seals, introducing a risk to sterility.
FDA Determined
Cause 2		Process control
ActionOn 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 recall@coopersurgical.com.
Quantity in Commerce2,340 (US only)
DistributionDomestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MQK
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