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CooperSurgical, Inc. recalls Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Inten
Recalled September 28, 2016 · FDA recall Z-2851-2016 · CooperSurgical
Hazard
Products contain international package insert and not the correct USA package insert · FDA Class III
Units
4 units
Sold at
Nationwide Distribution to CA, GA, and NY
Description
Products contain international package insert and not the correct USA package insert
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).
Manufacturer(s)
CooperSurgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →