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).
Reported: September 28, 2016 Initiated: August 25, 2016 #Z-2851-2016
Product Description
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).
Reason for Recall
Products contain international package insert and not the correct USA package insert
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 4 units
- 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) 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).. Recalled by CooperSurgical, Inc.. Units affected: 4 units.
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-2851-2016.
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