Animas battery caps on insulin pumps recalled

The FDA has announced a Class 1 nationwide recall of Animas Corporation battery caps used with the Animas 2020, IR1200 and IR1250 insulin pumps and OneTouch Ping System.

The recall notice describes intermittent loss of contact between the battery cap and battery compartment in the insulin pump that may result in the device resetting, potentially leading to hyperglycemia or hypoglycemia.

Animas Corporation and the FDA advised health care professionals to inform patients to replace the battery cap on their insulin pump.

The battery caps and insulin systems of concern include:

- All Animas battery caps manufactured from June 1, 2008 through July 31, 2008 and distributed from June 16, 2008 to Aug. 1, 2008.

- All OneTouch Ping Glucose Management Systems shipped before Aug. 1, 2008.

- All Animas 2020 Insulin Pumps shipped from June 16, 2008 to July, 19, 2008.

- All Animas IR1200 and IR1250 insulin pumps shipped from June 16, 2008 to Aug. 1, 2008.

Class 1 recalls are the 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, according to the FDA.

Animas Corporation sent warning letters to patients and distributors from Aug. 18, 2008 to Sept. 1, 2008, warning of the defective battery caps. The manufacturer provided replacement battery caps for patients and instructions for retrieval, replacement and disposal of defective battery caps for distributors. Animas Corporation will continue its efforts to contact all patients regarding the recall.

Meantime, health care professionals and consumers may report adverse events with use of these products to the FDA’s MedWatch Adverse Event Reporting program.