CooperSurgical, Inc. recalls Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intende…

Recall date

August 25, 2016

Source

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

Recall number

Z-2851-2016

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) 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).