Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE
FDA device recall Z-2850-2016 · posted 2016-09-20 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Products contain international package insert and not the correct USA package insert
- 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.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- MQL
- Quantity affected
- 1 unit
- Distribution
- Nationwide Distribution to CA, GA, and NY
- Date initiated
- 2016-08-25
- Date posted
- 2016-09-20
- Date terminated
- 2017-02-01
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI (K991390) | Sage Biopharma | 2000-01-18 |