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.
Reported: April 16, 2014 Initiated: March 5, 2014 #Z-1441-2014
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.
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 (-).
Details
- Recalling Firm
- Remington Medical Inc.
- Units Affected
- 41,499 cables
- Distribution
- USA (nationwide) Distribution including Canada
- Location
- Alpharetta, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Remington Medical Inc.. Units affected: 41,499 cables.
Why was this product 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 (-).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2014. Severity: Moderate. Recall number: Z-1441-2014.
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