FDA-Device2014-04-16Class II
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.
Remington Medical Inc.
Hazard
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 (-).
Sold states
USA (nationwide) Distribution including Canada
Affected count
41,499 cables
Manufactured in
6830 Meadowridge Ct, N/A, Alpharetta, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1441-2014Don't want to check this manually?
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