Recall of Animas insulin pumps listed as Class I
This article was originally published in The Silver Sheet
Executive Summary
FDA has categorized an August recall of battery caps used in the Animas OneTouch Ping, 2020, IR1200 and IR1250 insulin pump systems as Class I. The recalled battery caps were losing contact with the insulin pump's battery compartment, causing the pump to reset and temporarily lose power. This could cause either a loss of insulin delivery, resulting in hyperglycemia, or accidental overdosing by the user, resulting in hypoglycemia, FDA notes in its Nov. 20 announcement. Animas sent letters and replacement battery caps to customers from Aug. 18 to Sept. 1, and also sent letters to distributors