Z-2851-2016 Class III Terminated
FDA device recall Z-2851-2016 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: 4 units.
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
- 4 units
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
Distribution Pattern
Nationwide Distribution to CA, GA, and NY
Code Information
Lot no 16140184 expires April 2017 Lot no 15430149 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-2851-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026