Date Initiated by Firm | August 25, 2016 |
Date Posted | September 20, 2016 |
Recall Status1 |
Terminated 3 on February 01, 2017 |
Recall Number | Z-2851-2016 |
Recall Event ID |
75094 |
510(K)Number | K991390 |
Product Classification |
Media, reproductive - Product Code MQL
|
Product | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) 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 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 | 4 units |
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.
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510(K) Database | 510(K)s with Product Code = MQL
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