Recall of D-TRON adapters, used with D-TRONplus Insulin Pump

August 2, 2005 - Disetronic Medical Systems and FDA notified healthcare professionals and patients about a nationwide recall of D-TRON adapters, used with the D-TRONplus insulin pump, because they can potentially over-deliver a maximum amount of up to 1.8 I.U. (international units) of insulin. Use of these recalled adapters may pose a potential life-threatening situation to certain children using the pump. Other users who are insulin sensitive may also be at increased risk. The root cause of this issue is a sporadic failure of a valve inside the D-TRON adapter to close completely, which can result in a potential over-delivery of insulin.

The affected D-TRON adapters are part number REF 3000803, Lots 4013674 through 4022628. Other adapter lots are not affected.

Users should contact the Disetronic Pump User Support Group for information regarding replacement of affected D-TRON adapters at 1-800-688-4578. Users, caregivers and physicians who have questions about the recall may contact Disetronic Medical Systems, Inc. at 1-800-688-4578 24-hours a day, 365 days a year or visit www.disetronic-usa.com.

As always, pharmacies and members can contact the RxAmerica Customer Service Desk at 1-800-770-8014 if they have any questions about this product recall.