Reported Sep 28, 2016 · Terminated

Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017…

CooperSurgical, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350

Is this the product you have?

  • Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium
  • Product NumberART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA
Lot codes and dates
  • Lot No. 15420123 Expires Oct. 2016
Amount recalled
1 unit

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 1, 2017 · Data as of Sep 19, 4:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.