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U.S. Department of Health and Human Services

Class 2 Device Recall BIOPSY MEDIUM

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  Class 2 Device Recall BIOPSY MEDIUM see related information
Date Initiated by Firm December 15, 2022
Date Posted January 31, 2023
Recall Status1 Open3, Classified
Recall Number Z-1044-2023
Recall Event ID 91438
510(K)Number K060983  
Product Classification Media, reproductive - Product Code MQL
Product BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
Code Information Lot Number: 220506-006557
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
Manufacturer Reason
for Recall		 The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
FDA Determined
Cause 2		 Labeling Change Control
Action An "URGENT: VOLUNTARY MEDIA RECALL" letter dated 12/13/22 was sent to customers. Actions to be Taken: For both CUSTOMERS and DISTRIBUTORS: Inspect your stock for the Product from this lot. Lot information can be found on the box and bottle labeling. o If found, quarantine, and discontinue use of the Product from this lot immediately. o Return the Product to CooperSurgical through our Recall Return process. Credit will be applied to your account for reorder of correct product per our Recall process with no additional cost to you or your facilities. For CUSTOMERS: If you have the affected Product, contact CooperSurgical at Recall@coopersurgical.com. Or call +1-203-601-5200 and follow the phone prompt to enter the ext. 3300. If you received this letter (even if you do not have the specific lot remaining in stock), please complete and return the enclosed Customer Acknowledgement Form to Recall@coopersurgical.com. For DISTRIBUTORS: ¿ If the Product has been distributed to your customers, send this letter (including the Customer Acknowledgement Form) to your customers. ¿ Complete and return the enclosed Distributor Acknowledgement and Receipt Form to Recall@coopersurgical.com. Please feel free to reach us at +1-203-601-5200 and follow the phone prompt to enter the ext. 3300 or via email at Recall@coopersurgical.com.
Quantity in Commerce 489 units
Distribution Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria, Oman, Pakistan, Poland, Republic of North Macedonia, Saudi Arabia, Slovenia, Spain, Thailand, Turkey, Turkmenistan, and United Arab Emirates.
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 = MEDICULT A/S
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