Watch out for leaky insulin cartridges, if you or someone you love uses an Animas insulin pump.
Animas, a unit of Johnson & Johnson, sent a letter to customers late last month that said some of its 2.0 mL cartridges might leak. I didn't notice that until today, when Bloomberg reported the action.
Leaks in the cartridges could mean people get less insulin than they need. The problem could also lead alarms on the pumps to fail in some circumstances. The recall of leaky cartridges is the latest in a parade of quality-related problems at Johnson & Johnson.
Figuring the news trigger was the Food and Drug Administration deciding to officially classify the action a recall, I searched the agency site for news. Nothing doing.
I called Animas, and a spokeswoman said the company notified the FDA and posted the letter on its website during the last full week in February. So far, she said, there's been no word back from the agency on how it views the recall.
All told, Animas says six lots of cartridges are affected (five in the United States and one in France). That amounts to about 384,000 cartridges, or 5 percent of annual production.
The affected lots are:
- B201575 (USA)
- B201576 (USA)
- B201581 (USA)
- B201582 (USA)
- B201583 (USA)
- B201580 (France)
Nobody has been hospitalized or seriously injured, the spokeswoman said. There were 22 unspecified adverse events, but no deaths.
Oh, and I really do need to pay more attention to bloggers. Amy Tenderich over at Diabetes Mine had the straight dope on the Animas recall back on Feb. 22. If you want more details, check out her post.