CooperSurgical, Inc. recalls Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAG…

Recall date

August 25, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2850-2016

FDA classification

Class III

Brand / firm

CooperSurgical, Inc.

Sold / distributed

Nationwide Distribution to CA, GA, and NY

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What 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