Reported Apr 16, 2014 · Terminated
FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit…
Remington Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Remington Medical Inc. · 6830 Meadowridge Ct · Alpharetta, GA · 30005-2202
Is this the product you have?
- 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 codes and dates
Lot numbers 131901132262132263132533132693132694132833 132835132986and 133171
- Amount recalled
- 41,499 cables
Where it was sold
- Nationwide
Why it was recalled
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 (-).
This product could cause temporary or reversible health problems — stop using it.
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