Z-2850-2016Class III

Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART...

Name: Z-2850-2016 Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART...
Creator: CooperSurgical, Inc.
Published: 2016-08-25
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2016-08-25 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A... on 2016-08-25. FDA classified it as Class III and gives the reason as "Products contain international package insert and not the correct USA package insert". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2850-2016
Classification: Class III
Status: Terminated
Initiated: 2016-08-25
Posted: 2016-09-20
Terminated: 2017-02-01
Recalling firm: CooperSurgical, Inc.
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
Product code: MQL Media, Reproductive
Reason for recall: Products contain international package insert and not the correct USA package insert
Root cause tag: packaging
FDA 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 in commerce: 1 unit
Distribution: Nationwide Distribution to CA, GA, and NY
Product codes and lots: Lot No. 15420123 Expires Oct. 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2850-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2850-2016	Class III	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-20
Z-2851-2016	Class III	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-20

Product code MQL

K991390Class II1.5 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)