Device product
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
Z-2850-2016
Product summary
- Event
- Event 75094
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2850-2016
Official wording
Reason: Products contain international package insert and not the correct USA package insert
Code information: Lot No. 15420123 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