The Recall Desk
HighFDA (Devices)·Z-0816-2013·Announced 2013-02-20

Richmar Cloth Electrodes Recalled for Terminal Separation Defect

NAImco Inc dba Richmar Inc is recalling cloth electrodes where the socket terminal may pull away from the lead wire.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a risk of harm (electrical connection failure) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

NAImco Inc dba Richmar Inc is recalling specific cloth electrodes with Silver-Carbon construction. The affected products include various sizes and part numbers, all with serial numbers distributed between November 1, 2009, and January 31, 2010. The total quantity involved is 25,860 electrodes.

The recall is due to a defect where the electrode socket terminal may pull away from the electrode lead wire when the electrical stim lead wire is removed. This issue could compromise the integrity of the electrical connection during use.

The affected electrodes were distributed in the states of Georgia and Tennessee. Users should stop using the recalled electrodes and contact the manufacturer for instructions on replacement or refund.

The recalled product

Product
Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9241, Cat No. 400-895, 2" Round Electrode, Cloth, AG, All Serial Nu
Manufacturer
NAImco Inc dba Richmar Inc
Category
Medical Device — Electrodes
Hazard
Affected units
25,860

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 (1)

  • All Serial Numbers distributed between 11/01/2009 and 01/31/2010

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 4 recalled by NAImco Inc dba Richmar Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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