Recall Z-2851-2016— CooperSurgical, Inc.

Name: FDA recall Z-2851-2016
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) 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).. 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) 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).

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.