Z-2850-2016 Class III Terminated
FDA device recall Z-2850-2016 was initiated by CooperSurgical, Inc. on Aug 25, 2016 and is designated Class III. Reason for recall: Products contain international package insert and not the correct USA package insert The recall status is terminated (terminated Feb 1, 2017). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 28, 2016
- Initiation Date
- Aug 25, 2016
- Termination Date
- Feb 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
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
Reason for Recall
Products contain international package insert and not the correct USA package insert
Distribution Pattern
Nationwide Distribution to CA, GA, and NY
Code Information
Lot No. 15420123 Expires Oct. 2016
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2850-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026