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Recall Observatory FDA recall evidence

Device product

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

Z-2147-2015

July 06, 2015

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 71597
Status
Terminated
Classification
Class II
Quantity
6,344,700
Official record key
device-enforcement:Z-2147-2015

Official wording

Reason: Product marketed without a 510(k)

Code information: All lot numbers

Distribution pattern: Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product marketed without a 510(k)