FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.
The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius.
The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.
The company received reports of clinically significant fluid imbalance.
When a certain level of fluid imbalance is detected the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. By repeatedly overriding the balance alarm without solving the issue, such as a closed clamp or kinked line, it is possible to remove too much fluid from or replace too much fluid to the patient.
In extreme cases, this could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death. Public Contact: Baxter International, Inc. is the U.S. distributor of the Aquarius.
For questions regarding the Aquarius, contact the Baxter Clinical Help Line at 1-888-736-2543.
Friday, January 29, 2010
Monday, January 25, 2010
Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes
Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump).
These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.
Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.
This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011). The firm voluntarily recalled the products after learning of the possibility of needle detachment.
FDA has been apprised of this action. No injuries have been reported to date.
Product was distributed nationwide, including Puerto Rico.
Company is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products.
Consumers with questions may contact the company at 305.599.7174 x249.
These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection.
Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.
This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011). The firm voluntarily recalled the products after learning of the possibility of needle detachment.
FDA has been apprised of this action. No injuries have been reported to date.
Product was distributed nationwide, including Puerto Rico.
Company is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products.
Consumers with questions may contact the company at 305.599.7174 x249.
Friday, January 22, 2010
Helping Haiti
President Bill Clinton and President George W. Bush have established the Clinton Bush Haiti Fund for donations for the relief and support of Haiti.
The American Red Cross is working with its partners to assist those affected by this disaster. To contribute, please visit the RedCross online.
Health professionals wishing to go to Haiti, individuals, organizations, and companies wishing to make monetary contributions, or donate medical supplies or equipment, should register and indicate what resources they have at http://www.cidi.org.
For more ways to help, visit the Center for International Disaster Information (CIDI) site.
The American Red Cross is working with its partners to assist those affected by this disaster. To contribute, please visit the RedCross online.
Health professionals wishing to go to Haiti, individuals, organizations, and companies wishing to make monetary contributions, or donate medical supplies or equipment, should register and indicate what resources they have at http://www.cidi.org.
For more ways to help, visit the Center for International Disaster Information (CIDI) site.
Friday, January 8, 2010
Preparing for Disasters makes Renal & Urology News' "Top 10" List
http://www.renalandurologynews.com/dialysis-chains-prepare-for-disaster/article/123903/
Dialysis Chains Prepare for Disaster
For most patients with end-stage renal disease, dialysis centers provide crucial, even lifesaving, treatment. But are dialysis facilities prepared for emergencies?
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