Reported Sep 28, 2016 · Terminated
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018…
CooperSurgical, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation)
- Thawing Medium Product NumberART-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)
- Lot codes and dates
- Lot no 16140184 expires April 2017 Lot no 15430149 expires Oct. 2016
- Amount recalled
- 4 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Products contain international package insert and not the correct USA package insert
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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