Device product
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.
Z-1441-2014
Product summary
- Event
- Event 67752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41,499 cables
- Official record key
device-enforcement:Z-1441-2014
Official wording
Reason: 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 (-).
Code information: Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.
Distribution pattern: USA (nationwide) Distribution including Canada
Derived failure modes
-
Unknown
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 (-).