Device Recall WarmGel Infant Heel Warmer

  • Model / Serial
    All lot numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.
  • Product Description
    Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : || CooperSurgical || PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; || PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and || Fisher Brand. || PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; || PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    CooperSurgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • Manufacturer Parent Company (2017)
  • Source
    USFDA