The Recall Desk
ModerateFDA (Devices)·Z-1441-2014·Announced 2014-04-16

Remington Medical Recalls FAS-LOC Extension Cables Due to Labeling Error

Remington Medical is recalling FAS-LOC 6 Foot Disposable Extension Cables because the instruction manual incorrectly displays the polarity for the black connector.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect polarity symbol) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Remington Medical Inc. is recalling 41,499 units of the FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. These sterile, disposable electrical extension cables are intended to transmit signals from, or power or excitation signals to, patient-connected electrodes. The affected products were distributed nationwide in the United States and in Canada.

The recall was initiated because of an error in the Instructions for Use (IFU) document, specifically part number IFU-RM-0154 for the FL-601-97 model. The error involves the polarity symbol for the black chuck in the illustration; the manual incorrectly displays a plus sign (+) where it should display a minus sign (-). The affected lot numbers are 131901, 132262, 132263, 132533, 132693, 132694, 132833, 132835, 132986, and 133171.

Healthcare facilities and consumers should stop using the affected cables and contact Remington Medical for instructions on how to return the product or obtain a replacement. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.

The recalled product

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.
Affected units
41,499

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Lot numbers 131901
  • 132262
  • 132263
  • 132533
  • 132693
  • 132694
  • 132833 132835
  • 132986
  • and 133171.

Distribution

Distributed nationwide across the United States.