Class 2 Device Recall MediCult Vitrification Cooling Media

• Date Initiated by Firm: September 08, 2020
• Create Date: October 13, 2020
• Recall Status: Terminated on January 11, 2021
• Recall Number: Z-0100-2021
• Recall Event ID: 86479
• 510(K)Number: K100367
• Product Classification: Media, reproductive - Product Code MQL
• Product: MediCult Vitrification Cooling Media, Model Number 12284001F
• Code Information: Lot: 20230080
• FEI Number: 1216677
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 95 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: 203-601-9818
• Manufacturer Reason for Recall: There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.
• FDA Determined Cause: Under Investigation by firm
• Action: URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE letters dated 9/8/20 were sent to customers. Our records indicate that you have purchased the affected Product from CooperSurgical. The affected Vitrification Medium Product is of the correct formulation and functionally acceptable per quality release specifications and will work as intended in accordance with the accompanying Instructions For Use. Please discontinue use of and quarantine the Products, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected Products are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to indicate that and return it to CooperSurgical so that we may document receipt of this Field Safety Notice. The Chinese Food and Drug Administration has been notified of this Field Safety Notice. We sincerely apologize for any inconvenience caused by this Field Safety Notice. CooperSurgical is committed to high quality, safe and effective products. Please feel free to reach us at +001.203.601.5200 ext. 3300.
• Quantity in Commerce: 531 total boxes
• Distribution: The products were distributed to China.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MQL