Device recall: Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454…
Class II FDA enforcement event 63927. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
NAImco Inc dba Richmar Inc started this device recall on 30 Nov 2009. The firm address in the FDA record is in Chattanooga, TN. FDA put the recall in Class II. FDA event 63927 has 4 product records. The first FDA enforcement report date is 20 Feb 2013. The record gives the status Terminated, with the termination date 3 Sep 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed in the states of GA and TN.
Recalling firm
NAImco Inc dba Richmar Inc, Chattanooga, TN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0815-2013 | Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340,… | 209860 electrodes | Class II | Terminated | 20 Feb 2013 |
| Z-0816-2013 | 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 Numbers distributed between 11/01/2009 and… | 25860 electrodes | Class II | Terminated | 20 Feb 2013 |
| Z-0817-2013 | Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1271, Cat Nos.: 201-127, 202-093, 203-483, 203-565, 203-673, and 400-873, 2" x 2"… | 129400 electrodes | Class II | Terminated | 20 Feb 2013 |
| Z-0818-2013 | 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 Numbers distributed between 11/01/2009 and… | 56980 electrodes | Class II | Terminated | 20 Feb 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2009
- 26
- Share of these events in Class II
- 85%
- Product records in this event
- 4
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0815-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 63927. https://recallregister.com/fda/ii/63927/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed in the states of GA and TN.
- What quantity of product is in FDA event 63927?
- The event has 4 product records. The first record gives this quantity:
209860 electrodes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2009 have the same class?
- 85% of the 26 device events that started in 2009 are in Class II.