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U.S. Department of Health and Human Services

Class 2 Device Recall HealthPort BioAnologics Patient Electrode Sensor Test Kit,

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  Class 2 Device Recall HealthPort BioAnologics Patient Electrode Sensor Test Kit, see related information
Date Initiated by Firm February 08, 2011
Date Posted May 04, 2011
Recall Status1 Terminated 3 on July 25, 2011
Recall Number Z-2136-2011
Recall Event ID 58052
Product Classification Patient electrode sensor kit - Product Code IKD
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.
Code Information 4 lots affected: 198459, Exp. 02-2012; 200026, Exp. 03-2012; 203031, Exp. 08-2012; 204885, Exp. 12-2012
Recalling Firm/
Manufacturer		 Vermed, Inc.
9 Lovell Dr.
Bellows Falls VT 05101
For Additional Information Contact Nicole Barnett
802-722-9976
Manufacturer Reason
for Recall		 Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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