PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: September 28, 2016 Initiated: August 25, 2016 #Z-2850-2016

Product Description

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

Reason for Recall

Products contain international package insert and not the correct USA package insert

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
1 unit
Distribution
Nationwide Distribution to CA, GA, and NY
Location
Trumbull, CT

Frequently Asked Questions

What product was recalled?
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. Recalled by CooperSurgical, Inc.. Units affected: 1 unit.
Why was this product recalled?
Products contain international package insert and not the correct USA package insert
Which agency issued this recall?
This recall was issued by the FDA Devices on September 28, 2016. Severity: Low. Recall number: Z-2850-2016.