ANIMAS 2ml RESERVOIR RECALL

Important Message: Insulin Pump 2.0 mL Cartridge Recall

(From this page.)

Important Message: Animas Corporation has announced that some of the 2 mL insulin cartridges shipped between November 30, 2010 and January 4, 2011 can leak insulin, resulting in the delivery of less insulin than intended.

If the cartridge has a leak the pump may not alarm if there is an occlusion in the infusion set.

The manufacturer is asking distributors to check supplies immediately and report affected cartridges to Animas Corporation because under-delivery of insulin can cause serious injury or death. Animas will notify customers directly and provide them with a free replacement supply of new cartridges as well as instructions for returning their affected supply.

The lot numbers affected by this recall are:

B201575
B201576
B201581
B201582
B201583
The lot number can be found on the side panel of the cartridge box and on the packaging of each individual cartridge next to the symbol LOT.

There is not a problem with the pump. Leaking of insulin from the cartridge will not damage the pump.