Friday, October 29, 2010

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.

Monday, October 18, 2010

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.

Recall Notice: CareFusion Corp. Issues Recall of Alaris PC Units (Model 8015) Due to Potential For Delay or Interruption of Therapy

On October 15, 2010, CareFusion Corporation issued a recall of its Alaris PC Units (Model 8015) manufactured between the time period of December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010. The organization identified that under certain wireless network conditions, a communication error can occur which can lead to the freezing/interruption of the PC Unit screen and a subsequent delay in therapy. Should the communication error occur during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy which could lead to serious injury or death. Any users experiencing this problem should remove the device from service and contact the CareFusion Recall Center immediately at 888.562.6018 or via email at SupportCenter@carefusion.com. Corrective action will require a hardware update to all affected units. Please also note that CareFusion does not require that the devices be returned. Click here for more information.