Bayer Recalls CONTOUR TS Test Strips

Test Strip Recall for CONTOUR TS

December 21, 2007

Bayer Diabetes Care has initiated a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter. In the course of its routine quality control monitoring processes the Company identified a manufacturing issue with test strips from specific lots that could result in blood glucose readings with a positive bias that is outside of our product specifications. Test results may demonstrate results 5 -17% higher.

This issue is unrelated in any way to the Contour TS meter itself and pertains only to certain test strips used with the meter. Additionally, this issue has no impact on the performance of strips used with other Bayer meters including Ascensia Contour and Ascensia Breeze2 systems.

The affected Contour TS strips were produced during the initial manufacturing process on new manufacturing equipment designed for the new Contour TS strips. The root cause of the problem has been identified, and corrective actions implemented including additional quality control measures to prevent recurrence. The quality of our products and the results our customers receive are very important to Bayer and, as such, we are notifying regulatory authorities, healthcare professionals and customers in the countries where Contour TS is marketed – France, Austria, Turkey, Korea, Mexico, India and predominantly through mail order channels in the United States.

Healthcare providers, retailers, patients and other customers who use Contour TS are advised to check the lot number on the bottles of Contour TS strips and to contact Bayer Diabetes Care for information regarding return and replacement of strips. The lot numbers can be found on the bottom of the box and on the side of the bottle containing the strips. The affected lots begin with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters (for example WK7ED3E52C). Only bottles of test strips with the characters 7D, 7E, 7F, or 7G in the third and fourth position in the sequence are affected. Bottles with a lot number including 7J through 7M after WK are not affected and need not be returned. Additional information can be found at www.bayerdiabetes.com. Please call your Bayer customer service phone number (in the U.S., call 1-800-348-8100) to return any affected bottle of strips and to get a replacement.

tag: bayer, FDA, Medical Tool Recall, Contour TS, Blood Glucose Meter, Diabetes, Contour TS strips

Cardinal Health Recalls Alaris Pump Module

Contact: Jim Mazzola (614) 757-3690

FOR IMMEDIATE RELEASE --DUBLIN, OH -- December 20, 2007 --- Cardinal Health today issued the following update to the company’s worldwide voluntary recall for its Alaris® Pump module:

On Nov. 5, 2007, Cardinal Health notified customers of a voluntary recall for all Alaris® Pump modules, model 8100 (formerly known as Medley™ Pump module), shipped prior to Sept. 27, 2007. Serial numbers for affected devices can be found at www.cardinalhealth.com/alaris/indexmodulealert.asp.

The reason for this recall is that the units may contain misassembled occluder springs (bent, broken, nested or missing). These conditions have occurred due to misassembly during manufacturing. Misassembled springs could lead to overinfusion that could result in serious adverse health consequences or death. Overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there is no warning or notification of an overinfusion.

The company became aware of the issue from a review of customer complaints and service data. Cardinal Health has received one report of an injury and two reports of patient deaths associated with the use of this device. The deaths could not be confirmed by the respective hospitals or Cardinal Health as definitively caused by this issue.

Instructions to Customers

Any customer inquiries related to this action should be addressed to Cardinal Health’s customer service center at 1-800-625-6627, with representatives available 24 hours a day, seven days a week. Additional information about the voluntary recall can also be found at www.cardinalhealth.com/alaris/indexmodulealert.asp.

Cardinal Health will work with customers to minimize disruption while completing an inspection of the devices as quickly as possible at the company’s service facility and repairing those units with misassembled springs. This includes dispatching field teams to customer sites and using a loaner pool of temporary substitute Alaris pump modules with hospitals while their pumps are being inspected at Cardinal Health's facility. Any devices found with misassembled springs will be repaired and then returned to the customer, along with their other devices that have passed inspection.

In the interim, the company has developed an occluder pressure test to provide customers a method to potentially identify affected devices prior to Cardinal Health’s inspection. The occluder pressure testmay not be effective in detecting all misassembled occluder springs, and a further inspection by the company is required. This test method was posted as an updated service bulletin 528A at www.cardinalhealth.com/alaris/indexmodulealert.asp. Follow hospital protocol related to monitoring that your infusion pumps are functioning correctly during use.

Cardinal Health notified customers by registered letter, posted the customer letter on the Cardinal Health web site and set up a dedicated call center for customer support. The Food and Drug Administration (FDA) has also been apprised of this action. The voluntary recall covers Alaris® Pump modules that were distributed to 46 states, the District of Columbia, Canada, Guam, Puerto Rico and Saudi Arabia. There have been approximately 201,000 Alaris® Pump modules distributed worldwide that are affected by this recall. All units shipped after Sept. 27, 2007 have undergone a new inspection process to confirm correct assembly of the occluder springs, and therefore the company has not included these units as part of this recall. The company is working on product improvements to the pump to minimize the possibility for future misassembly of the springs.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch web site at www.fda.gov/medwatch.

Tags: Medical recall, Alaris® Pump module recall, Cardinal Health Recall, FDA Recall