Z-2136-2011

HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton Each kit...

Name: Z-2136-2011 HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton Each kit...
Creator: Vermed, Inc.
Published: 2011-02-08
License: https://open.fda.gov/license/

Graphic Controls Acquisition Corp.dba Nissha Medical Technologies / initiated 2011-02-08 / Terminated

FDA source

Vermed, Inc. began a recall of HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton Each kit contains 100 tab electrodes and 26 alcohol pads. The... on 2011-02-08. The reason FDA records is "Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2136-2011
Status: Terminated
Initiated: 2011-02-08
Posted: 2011-05-04
Terminated: 2011-07-25
Recalling firm: Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
Product: HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton Each kit contains 100 tab electrodes and 26 alcohol pads. The electrodes are used to measure bodyfat analysis. The alcohol pads (non-sterile) are used for cleaning the skin to help the electrodes adhere better. There are no instructions for use with the kit.
Product code: IKD Cable, Electrode
Reason for recall: Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination.
FDA root cause: Other
Action: Vermed sent consignee a recall notification letter on February 8, 2011, followed by a phone call and email. The consignee was instructed to respond with a Recall Reply Form via fax and to notify any customers to whom the affected product was further distributed. All recalled alcohol prep pads were to be returned to Triad Group. Firm is replacing Triad alcohol pads in kits with pads from another supplier and has removed Triad from its approved vendor list. For questions regarding this recall call 802-722-9976.
Quantity in commerce: 2500 kits total; 500 from each lot except 1000 from Lot 203031
Distribution: OR
Product codes and lots: 4 lots affected: 198459, Exp. 02-2012; 200026, Exp. 03-2012; 203031, Exp. 08-2012; 204885, Exp. 12-2012

Product code IKD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)