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U.S. Department of Health and Human Services

Class 3 Device Recall Sage InVitro Fertilization

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  Class 3 Device Recall Sage InVitro Fertilization see related information
Date Initiated by Firm August 25, 2016
Date Posted September 20, 2016
Recall Status1 Terminated 3 on February 01, 2017
Recall Number Z-2850-2016
Recall Event ID 75094
510(K)Number K991390  
Product Classification Media, reproductive - Product Code MQL
Product Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017
SAGE In Vitro Fertilization, Inc.
A CooperSurgical Company
95 Corporate Drive
Trumbull, CT 06611 USA
Code Information Lot No. 15420123 Expires Oct. 2016
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact SAME
203-601-5200
Manufacturer Reason
for Recall		 Products contain international package insert and not the correct USA package insert
FDA Determined
Cause 2		 Packaging change control
Action CooperSurgical sent an Advisory Notice dated August 25, 2016, to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. The advisory notification asked customers to replace the previously inserted incorrect Instructions for use (IFU) with the correct IFU sent with the advisory notification. For questions regarding this recall call 203-601-5200.
Quantity in Commerce 1 unit
Distribution Nationwide Distribution to CA, GA, and NY
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 and Original Applicant = SAGE BIOPHARMA
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