CLASS II Device recall · Reported 16 Apr 2014 · FDA Enforcement Report
Fas-loc 6 Foot Disposable Extension Cable recalled by Remington Medical
Remington Medical is recalling Fas-loc 6 Foot Disposable Extension Cable with Safe Connect/Screw Down, distributed nationwide in the US. The recall was initiated on 5 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1441-2014
- FDA event ID
- 67752
- Recalling firm
- Remington Medical, Alpharetta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2014
- FDA classified
- 9 Apr 2014
- Reported
- 16 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Mar 2014 | Recall initiated by company | |
| 9 Apr 2014 | Classified by FDA | +35 days |
| 16 Apr 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 (-).
Product as listed by the FDA
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.
Where it was distributed
USA (nationwide) Distribution including Canada
Questions about this recall
Why was it 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 lots are affected?
Lot numbers 131901, 132262, 132263, 132533, 132693, 132694, 132833 132835, 132986, and 133171.
Where was it sold?
USA (nationwide) Distribution including Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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