A Class I recall has been issued for battery caps included with some varieties of Animas insulin pumps. According to Animas Corp, the defective battery caps could cause the pumps to stop administering insulin, putting patients at risk of hyperglycemia or hypoglycemia.
The products involved in this recall include:
- All Animas 2020 Insulin Pumps shipped between June 16, 2008 through July 19, 2008
- All Animas IR 1200 and IR 1250 Insulin Pumps shipped between June 16, 2008 through August 1, 2008
- All OneTouch Ping Glucose Management Systems shipped prior to August 1, 2008
- All Battery caps shipped between June 16, 2008 through July 19, 2008
According to the Animas Corp. recall notice, some battery caps on these devices do not maintain contact with the pump’s battery compartment. When the cap loses contact with the battery compartment, the insulin pump will temporarily lose power. A power loss can cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia).
Beginning in August, Animus began notifying insulin pump users of this recall. In order to ensure the safe operation of the pump, and avoid any potential power loss related to this battery cap issue, users of the affected Animas insulin pumps were told to:
- Immediately replace the battery cap on the Animas insulin pump with the battery cap enclosed with the recall notice.
- Discard and do not use the defective battery cap from their Animas insulin pump.
Class 1 recalls are the Food & Drug Administration’s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Users of Animas insulin pumps who need more information on this recall can call the company at 1-866-423-4087, Monday through Friday from 8:00 a.m. until 7:00 pm Eastern Standard Time.
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