Recall Z-2136-2011 ยท IKD Cable, Electrode
Vermed, Inc.
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.
| Date | May 4, 2011 (initiated Feb 8, 2011) |
| Status | Terminated |
| Reason | Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination. |
| 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 | 2500 kits total; 500 from each lot except 1000 from Lot 203031 |
| Distribution | OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.