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Terminated

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

FDA Recall Z-2850-2016 · Posted 2016-09-20

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeMQL
Date Initiated2016-08-25
Date Terminated2017-02-01
Product Quantity1 unit

Reason for Recall

Products contain international package insert and not the correct USA package insert

Firm 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.

Root Cause

Packaging change control

Distribution Pattern

Nationwide Distribution to CA, GA, and NY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K9913901.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDISage Biopharma · 2000-01-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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