The Recall Desk
HighFDA (Devices)·Z-0818-2013·Announced 2013-02-20

Richmar Foam Electrodes Recalled for Terminal Separation Defect

NAImco Inc dba Richmar Inc is recalling foam electrodes where the socket terminal may pull away from the lead wire. The defect poses a risk of electrical shock or injury.

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 presents a risk of harm (electrical shock/injury) without reported illnesses or injuries in the source text.

Plain-English summary

NAImco Inc dba Richmar Inc is recalling specific lots of foam electrodes with Silver-Carbon construction. The recall involves 56,980 units of various sizes and part numbers, all distributed between November 1, 2009, and January 31, 2010. These products were distributed in the states of Georgia and Tennessee.

The recall was initiated because the electrode socket terminal may pull away from the electrode lead wire when the electrical stim lead wire is removed. This defect could result in the terminal separating from the lead wire, potentially exposing users to electrical hazards or causing injury during use.

Healthcare facilities and consumers who possess these specific foam electrodes should stop using them immediately. Users should contact the recalling firm, NAImco Inc dba Richmar Inc, for instructions on how to return the affected products for a refund or replacement.

The recalled product

Product
Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x 2" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Cat No. 202-9281, 2" Round Electrode, Foam, AG, All Serial Numb
Manufacturer
NAImco Inc dba Richmar Inc
Category
Medical Device — Electrodes
Hazard
Affected units
56,980

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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