Recall Z-1441-2014— Remington Medical Inc.
Class II · Terminated
Class II FDA medical device recall by Remington Medical Inc., initiated 2014-03-05, terminated 2018-04-09. It names one FDA 510(k) clearance: K971968. 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.. 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 (-)..
- Recalling firm
- Remington Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-05
- Terminated
- 2018-04-09
- Firm location
- Alpharetta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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 (-).
Data sourced from openFDA. This site is unofficial and independent of the FDA.