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Recall Observatory FDA recall evidence

Device product

CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection

Z-1298-2015

January 26, 2015

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 70286
Status
Terminated
Classification
Class II
Quantity
20398889 units
Official record key
device-enforcement:Z-1298-2015

Official wording

Reason: Products without expiration date have the remote potential for minor burn

Code information: Products without an expiration date and lot number

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products without expiration date have the remote potential for minor burn