The Recall Desk

FDA (Devices) recall action 75094

CooperSurgical, Inc. recalled 2 products on 2016-09-28

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-09-28
Critical
0
Units
5

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2016-09-28

    CooperSurgical Recalls Sage CSC Thawing Medium Due to Incorrect Package Insert

    CooperSurgical, Inc. is recalling 4 units of Sage CSC Thawing Medium because the products contain an international package insert instead of the correct USA package insert.

    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…
    Category
    Distribution
    3 states
  • LowFDA (Devices)··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.

    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
    Category
    Distribution
    3 states