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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Event Detail

Event ID 67752
Product Type Devices
Status Ongoing
Recalling Firm Remington Medical Inc.
City Alpharetta
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-05
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern USA (nationwide) Distribution including Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device. Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171. Class II Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-). 41,499 cables Z-1441-2014
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