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 A Letter To Customers: --URGENT Medical Device Recall: OneTouch® UltraSmart® Meters with serial numbers starting in TC, TD, TF or TG-- November 17, 2006 Please pay special attention to this product notification if you use a OneTouch® UltraSmart® Blood Glucose Meter and the serial number on the back of your meter begins with any of the specific two-letter combinations: TC, TD, TF or TG.
If you do not have a OneTouch UltraSmart Meter, or you do but your serial number does not begin with one of the specified two-letter combinations, this issue does not apply to you and you may disregard this notice. If this issue does apply to you, then this notice is to inform you that, due to a potential issue with leaking batteries in certain OneTouch UltraSmart Blood Glucose Meters, LifeScan is replacing the batteries in the OneTouch UltraSmart Meters affected by this issue and, when necessary, the meters themselves. Leaking Batteries in Certain OneTouch UltraSmart MetersEvery OneTouch UltraSmart Meter comes with two AAA batteries already installed in the back of the meter. LifeScan has recently become aware that certain OneTouch UltraSmart Meters shipped in 2005 (serial numbers beginning with TC, TD, TF or TG) may contain batteries with a higher-than-normal chance for leakage. This leakage in the meter's battery compartment could cause residue and/or corrosion, which could—in turn—damage the battery contacts and/or cause the batteries to die sooner than normal. As a result, your meter may not turn on or will show a battery warning earlier than would normally be expected.
Please be aware that this issue does not affect any other LifeScan Products. What You Should Do For Consumers Please call LifeScan Customer Service, 866 621-4851, if you have a OneTouch UltraSmart Blood Glucose Meter and the serial number on the back of your meter begins with: TC, TD, TF or TG. When you call, the Customer Service representative will help you determine if your meter's batteries or the meter itself need replacement. If they do, LifeScan will send you the necessary replacement batteries or meter at no charge. Continue to Test Your Blood SugarIf you call LifeScan and we arrange to send you new batteries or a new OneTouch UltraSmart Meter, please ensure that you continue to properly manage your diabetes while waiting for your replacement. While you wait for replacement batteries, you may continue to test with your OneTouch UltraSmart Meter if it still turns on and allows you to perform a test. (You can rely on the OneTouch UltraSmart Meter to provide accurate results.) For Health Care Professionals and Pharmacists/Distributors 2. Pharmacists/Distributors: Please compare the lot numbers of any OneTouch UltraSmart Meters in your inventory and sequester any inventory of OneTouch UltraSmart Meters you have that are subject to recall—only the specified lot numbers. If you do not have product from the specified lot numbers, your meters are not subject to this recall. Return the recalled OneTouch UltraSmart Meters per your normal return procedure. 3. We also ask that you share this information with any of your patients/customers who use a OneTouch UltraSmart Meters. How to Contact LifeScanWe apologize for any confusion or inconvenience this issue may cause you. If you have any additional questions, please contact us directly:
For Health Care Professionals/Pharmacists/Distributors
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