Medical device recalls Moderate risk

CooperSurgical, Inc. recalls NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use…

Recall date
January 26, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1301-2015
FDA classification
Class II
Brand / firm
CooperSurgical, Inc.
Sold / distributed
Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.

Why it was recalled

Products without expiration date have the remote potential for minor burn

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection

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