Recall Z-2851-2016 ยท MQL Media, Reproductive
CooperSurgical, Inc.
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).
| Date | Sep 20, 2016 (initiated Aug 25, 2016) |
| Status | Terminated |
| Reason | Products contain international package insert and not the correct USA package insert |
| Root cause | Packaging change control |
| Action | 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. |
| Quantity | 4 units |
| Distribution | Nationwide Distribution to CA, GA, and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991390 | 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI Sage Biopharma, Jan 18, 2000 |