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
FDA Recall Z-1300-2015 · Posted 2015-03-19
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Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeIMD
Date Initiated2015-01-26
Date Terminated2016-06-14
Product Quantity18696754 units
Reason for Recall
Products without expiration date have the remote potential for minor burn
Firm Action
CooperSurgical issued Recall Notification letter on January 26, 2015, via Fedex confirmed receipt delivery, to all affected customers. Customers were requested to review inventory and return/destroy product that does not have a expiration and lot number. A fax back form to be returned. Customers with questions should call 203.601.5200.
CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement.
Root Cause
Package design/selection
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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