Johnson & Johnson just can't seem to get a win; a unit of the pharma and medical device giant has recalled more than 380,000 potentially leaky insulin pump cartridges. And the recall comes with the disclosure of a warning letter to J&J's Cordis unit.
In a Feb. 24 letter, J&J unit Animas notified patients of the problem, saying the recall affects 2-milliliter cartridges shipped between Nov. 30 and Jan. 4. These cartridges can leak, resulting in the delivery of less insulin than intended. The letter states the under-delivery of insulin can cause high blood sugar and diabetic ketoacidosis--serious conditions that can lead to severe health issues, including death. In addition, if the cartridge has a leak, the pump may not alarm if there is a blockage in the infusion set, the letter said.
Animas spokeswoman Caroline Pavis told Reuters a total of 384,180 cartridges were recalled. They came from from five lots shipped in the U.S. and one in France. According to Pavis, there have been reports of 22 adverse events, but none involved hospitalization or death. She added the company became aware of the problem through customer complaints about insulin leaking from the plunger side of the cartridge.