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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 Fertilizationsee related information
Date Initiated by FirmAugust 25, 2016
Date PostedSeptember 20, 2016
Recall Status1 Terminated 3 on February 01, 2017
Recall NumberZ-2851-2016
Recall Event ID 75094
510(K)NumberK991390 
Product Classification Media, reproductive - Product Code MQL
ProductSage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).
Code Information Lot no 16140184 expires April 2017 Lot no 15430149 expires Oct. 2016
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactSAME
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
ActionCooperSurgical 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 Commerce4 units
DistributionNationwide Distribution to CA, GA, and NY
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MQL
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