Life Sciences

Animas issues Class I recall for battery caps

Device Regulation Alert: Safety, Compliance and Reimbursement News, December 1, 2008

Animas is recalling battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump, according to an FDA recall notice.

According to the notice, the battery cap may lose contact with the battery compartment, causing the device to shut off. As a result, the device may stop administering insulin, which could result in high glucose levels. It may also lead to confusion about the amount of insulin administered.

In a letter to patients, Animas advised them replace the battery cap. Animas also notified healthcare professionals of the recall and recommended they ensure their patients replace the battery cap.


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