The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-2850-2016·Announced 2016-09-28

Sage CSC Freezing Medium Recalled for Incorrect USA Package Insert

CooperSurgical is recalling Sage CSC Freezing Medium because it shipped with an international package insert instead of the correct USA version.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/packaging error (incorrect package insert) rather than a product defect or contamination.

Plain-English summary

CooperSurgical, Inc. is recalling one unit of Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium, Product Number ART-8017. The recall is due to a labeling error where the product contained an international package insert rather than the correct USA package insert.

The affected product is identified by Lot No. 15420123 and has an expiration date of October 2016. The product was distributed nationwide to California, Georgia, and New York.

Consumers and healthcare facilities should stop using the product and contact the recalling firm for instructions on how to return or dispose of the affected units.

The recalled product

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
Manufacturer
CooperSurgical, Inc.
Category
Medical Device — In-Vitro Fertilization
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot No. 15420123 Expires Oct. 2016

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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