Tandem Diabetes Care Insulin Cartridge Recall [US]


US FDA RecallUS/Silver Spring: Tandem Diabetes Care recalls some lots of Insulin Cartridges used with t:slim Insulin Pumps due to leakage, mis-dosage, injury, death hazards. FDA: http://ht.ly/sB6tT

Direct link: http://www.fda.gov/Safety/Recalls/ucm381473.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drug Administration Accessories are subject to this recall, listed by affected lot numbers:

  • M001963, M001964, M001973, M001974, M001979, M001980, M001987, M001988, M001990, M001991, M002027, M002028, M002029, M002030, M002082, M002083, M002096, M002097, M002099, M002100, M002119, M002120

According to the FDA, the recalled Insulin Cartridges may be at risk for leaking. The cause of the recall was identified during Tandem’s internal product testing and has not been associated with any complaints or adverse events reported by customers. However, an Insulin Cartridge leak could potentially result in the device delivering too much or too little Insulin. This could lead to a serious adverse health event, requiring immediate and urgent medical intervention.

Customers should discontinue using cartridges labeled with the below lot numbers, which were shipped on or after December 17, 2013. The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box).

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Recalls Direct RIN: 3002-2014
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org
E. & O. E.

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