Safety Alerts & Recalls

What does this mean?

Since the recalled t:slim Insulin Pump cartridges have the potential to cause adverse events, this alert should be taken seriously. If you have a t:slim Insulin Pump, please check your cartridges to see if they are labeled with one of the recalled lot numbers.

If you have one or more of the lot numbers of the recalled t:slim cartridges, you should stop using these cartridges and use cartridges from a lot that has not been recalled. You can call Tandem Technical Support to receive replacement cartridges at no charge. Tandem Customer Support is available 24 hours a day, 7 days a week at 1-877-801-6901. Tandem expects to have plenty of cartridges to replace affected lots in a timely manner.

If you are not sure if you have t:slim cartridges or if you have concerns about your insulin pump or insulin supply, please follow up with your healthcare provider as soon as possible.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: www.fda.gov/medwatch

Tandem Diabetes Care Issues Recall for Insulin Cartridges Used with t:slim Insulin Pump

Tandem Diabetes Care announced that it is recalling several lots of insulin cartridges that are used with the t:slim Insulin Pump. The recalled cartridges may be at risk for leaking. A cartridge leak could possibly result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

Affected lots were shipped on or after December 17, 2013 and include the following lot numbers: M001963, M001964, M001973, M001974, M001979, M001980, M001987, M001988, M001990, M001991, M002027, M002028, M002029, M002030, M002082, M002083, M002096, M002097, M002099, M002100, M002119, and M002120

All other cartridge lots and the t:slim Insulin Pump itself are not affected by this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2014-01-15
Last Updated: 2014-01-15

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