Animas Insulin Cartridge Recall Issued by Johnson & Johnson

Nearly 400,000 Animas Insulin Pump Cartridges, made by a Johnson & Johnson subsidiary, have been recalled because they may leak and fail to deliver enough insulin to patients, potentially resulting in serious injury or death. 

The insulin cartridge recall was announced at the end of February by Animas Corporation, which sent a letter to registered Animas insulin pump owners after the company was alerted to the leaking cartridges by customers.

As a result of the problems with the insulin cartridges, diabetics may not receive their full dose of medication, which could result in high blood sugar and a potentially fatal condition known as diabetic ketoacidosis. The leaking cartridges could also prevent the pump from issuing an alarm if there is a blockage in the infusion set. There have been two adverse events reported in connection to the leaking insulin cartridges, but neither reportedly required hospitalization.

The recall affects 384,180 2.0 milliliter Animas insulin pump cartridges. The cartridges were shipped to the U.S. and France and have lot numbers of B201575, B201576, B201581, B201582 and B201583. The lot numbers can be found on the side panel of the cartridge box and on the packaging of each cartridge. The cartridges were distributed between November 30, 2010 and January 4.

The recall represents 5% of the company’s total insulin production. Animas says it has already shipped replacement cartridges to all of its known customers. Anyone with questions or who has not received their replacement insulin cartridges can contact the Animas Cartridge Fulfillment Center at 1-877-280-2339.

This is the latest in a string of recalls by Johnson & Johnson and their subsidiaries that have been issued over the past year.

The Johnson & Johnson subsidiary Ethicon recalled more than half a million medical sutures due to sterility problems last week. In addition, Johnson & Johnson subsidiaries have also recalled 700,000 vials of Dermabond Topical Skin Adhesive and Simponi autoinjectors, as well as 70,000 syringes of Invega, in just the last month. All were recalled due to manufacturing problems.

In addition to the recalls, the FDA released a warning letter sent to Cordis Company, another Johnson & Johnson subsidiary, over quality control problems with stents manufactured at its Puerto Rico facility. The letter claims that the plant failed to ensure that the medical devices met specifications and failed to pursue known protocol failures involving their manufacture.