Monday, November 15, 2010

Recall Notice: Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

On November 15, 2010, the FDA and Sigma International Gerneral Medical Apparatus, LLC reiterated an earlier recall notice from September 15, 2010 regarding Sigma Spectrum Infusion Pump Model 35700. The recall includes pumps that have serial numbers from 706497 to 724065. The recall was issued because these units may fail suddenly, causing inaccurate flow conditons during use, ranging from back flow to over-infusion, including free flow. Also, of concern in that the pump does not issue and alarm when this occurs which could result in the serious injury of death of the user.

Should you be in possession of a recalled pump, Sigma is requiring the return of the devices. For questions and return information please, contact the company at 1-866-482-2893, Monday through Friday, 8 AM though 5 PM (Eastern Time). Click here for more information.

Thursday, November 11, 2010

Recall Notice: Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem

On October 8, 2010, WalkMed Infusion LLC. and the FDA notified healthcare professionals of a nationwide recall of the Triton Pole Mount Infusion Pump, serial numbers 001 through 500 and serial numbers TR1401 through TR 2559, manufactured and sold before June 2010. The issue stems from a problem with the latch alarm on the pump door which if gone unnoticed could potentially lead to an over infusion of medication to the patient. It is requested that consumers who have Triton Pole Mount Infusion Pumps which are being recalled should return the pump to the manufacturer. Click here for more information.