Recall Z-2850-2016— CooperSurgical, Inc.

Name: FDA recall Z-2850-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-25

Class III · Terminated

Class III FDA medical device recall by CooperSurgical, Inc., initiated 2016-08-25, terminated 2017-02-01. It names one FDA 510(k) clearance: K991390. Product: 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. Reason: Products contain international package insert and not the correct USA package insert.

Recalling firm: CooperSurgical, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-08-25
Terminated: 2017-02-01
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K991390 — 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDISage Biopharma·cleared 2000-01-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.