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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

Product Description 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.
Recall Number Z-1441-2014
Classification Class II
Code Info Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.
Product Distributed Qty 41,499 cables
Reason For Recall 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 (-).

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