FDA-Device2015-03-25Class II

MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection

CooperSurgical, Inc.
Hazard

Products without expiration date have the remote potential for minor burn

Sold states
Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.
Affected count
18696754 units
Manufactured in
75 Corporate Dr, Trumbull, CT, United States
Products
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1300-2015

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