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U.S. Department of Health and Human Services

Class 2 Device Recall LifeGlobal Fast Freeze Thawing Kit

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  Class 2 Device Recall LifeGlobal Fast Freeze Thawing Kit see related information
Date Initiated by Firm June 13, 2022
Create Date July 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-1421-2022
Recall Event ID 90469
510(K)Number K092963  
Product Classification Media, reproductive - Product Code MQL
Product LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Code Information UDI: (01)00815965020914 (17)220819 (10)GFT5-200218U (01)00815965020914 (17)220819 (10)GFT5-201026U (01)00815965020914 (17)220819 (10)GFT5-21335060  Lots: 21335060, GFT5-200218U, GFT5-201026U
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer Reason
for Recall		 There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.
FDA Determined
Cause 2		 Error in labeling
Action On June 13, 2022, the firm distributed Urgent Media Safety Notice letters to affected customers. Customers were informed that setting out a thawing blastocyte for 5 minutes may be detrimental to the survival of the blastocyte. Customers were asked to complete and return an acknowledgement form. Once the firm has received the completed form, they will provide the corrected IFU.
Quantity in Commerce 403 units
Distribution Domestic: USA AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VT, WA, WI, International: Belgium, Canada, Croatia, Netherlands, Portugal, Spain
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MQL and Original Applicant = GENX INTL., INC.
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