Device 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).
Z-2851-2016
Product summary
- Event
- Event 75094
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4 units
- Official record key
device-enforcement:Z-2851-2016
Official wording
Reason: Products contain international package insert and not the correct USA package insert
Code information: Lot no 16140184 expires April 2017 Lot no 15430149 expires Oct. 2016
Distribution pattern: Nationwide Distribution to CA, GA, and NY
Derived failure modes
-
Unknown
Products contain international package insert and not the correct USA package insert