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.

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.

Recall Notice: Heparin Sodium (B. Braun): Recall - Trace Contaminant

On October 29, 2010 B. Braun Medical Inc. and the FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated trace amounts of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010. Should you be in possession of this product discontinue use immediately. To identify product lot numbers, expiration dates, and recall instructions please, reference the Recall Notice contained in the following link. Click here for more information.

KCER Team Leader to Present at Upcoming ASN Renal Week Conference in Denver

Kenneth Lempert M.D., M.S.P.H. and a team leader for the KCER Physician Placement and Assistance Response Team will be part of a panel of experts presenting on a topic entitled, “Nephrology in Natural Disasters: What to do with Acute Kidney and End Stage Renal Disease Patients During Disasters.” As part of this distinguished group, Dr. Lempert will lead a discussion focusing specifically on the Impact of Disasters on Dialysis Patients’ Health. For those interested in attending this session the date, time, and location are as follows:

Date – November 19th 2010

Time – 4:30 p.m. to 6:30 p.m. PT

Location – Denver Four Seasons 2/3

For more information click here.

Recall Notice: Excelsior Medical Identifies Potential Loss of Sterility and Leaking in 5ml Fill in 6cc Prefilled Saline Flush Syringes

On October 15, 2010, Excelsior Medical issued a recall notice that several models of its Prefilled Saline Flush Syringes had the potential to leak and/or lose sterility. The recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Please note that using syringes that have a sterility issue could result in systemic infection, which may lead to serious injury and/or death. Should you be in possession of any of these syringes, please discontinue use immediately and return them to your point of purchase. It is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.