Recall Z-2851-2016
CooperSurgical, Inc. · initiated August 25, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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).
Codes / lots: Lot no 16140184 expires April 2017 Lot no 15430149 expires Oct. 2016
Reason for recall
Products contain international package insert and not the correct USA package insert
FDA-determined cause: Packaging change control
Action taken
CooperSurgical sent an Advisory Notice dated August 25, 2016, to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. The advisory notification asked customers to replace the previously inserted incorrect Instructions for use (IFU) with the correct IFU sent with the advisory notification. For questions regarding this recall call 203-601-5200.
Details
- Recall number
- Z-2851-2016
- Initiated
- August 25, 2016
- Posted by FDA
- September 20, 2016
- Terminated
- February 1, 2017
- Product code
- MQL – Media, Reproductive
- Quantity
- 4 units
- Distribution
- Nationwide Distribution to CA, GA, and NY
- Recalling firm
- CooperSurgical, Inc., Trumbull, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2850-2016 Class III | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium…Products contain international package insert and not the correct USA package insert | 08/25/2016Terminated |