Z-1441-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2014
- Initiation Date
- March 5, 2014
- Termination Date
- April 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41,499 cables
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 (-).
Distribution Pattern
USA (nationwide) Distribution including Canada
Code Information
Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.