Animus Issues Urgent Recall Notice to Insulin Pump Users

March 12th, 2011

In a rare development that all insulin dependent diabetics should be aware of, Johnson & Johnson has recalled around 384,000 cartridges for its Animus Insulin Pump.

To date, twenty-two injuries have been reported as a result of faulty insulin pump cartridges leaking at the side where the plunger is. The leaks can result in the diabetic using the cartridge receiving a lower insulin dosage than they intended.

Johnson & Johnson has posted an urgent notice on their Animus division website warning consumers to check their cartridge supply and to stop using any of the 2.0 ml cartridges in question immediately. It is also contacting insulin pump users, or as they refer to them, "insulin pumpers", that may have purchased the faulty cartridges, and shipping them replacement cartridges. The website notice reads in part:

Please note that under-delivery of insulin can cause high blood sugar and/or diabetic ketoacidosis. These are serious conditions that can cause severe health impact, including death. Symptoms of diabetic ketoacidosis may include nausea, vomiting, shortness of breath and excess thirst/urination. Contact your healthcare professional immediately if you are experiencing any of these symptoms.

Ketoacidosis usually develops slowly over 24 hours, starting with symptoms such as fatigue, mental stupor, decreased appetite, loss of appetite, headache, and fading consciousness. Other ketoacidosis symptoms all insulin dependent diabetics should be aware of include stomach or abdominal pain, a flushed complexion, and breath that smells like fruit or nail polish remover.

The insulin cartridge recall extends to the US and France. The recall applies only to lot numbers B201575, B201576, B201581, B201582 and B201583. The insulin pump cartridges in questions were shipped between November 30th, 2010 and January 4th, 2011.

Animas has provided the following instructions for insulin pumpers diabetics with a recalled insulin cartridge who need to disconnect their infusion sets:

1) Disconnect the infusion set from your body (failure to follow these important safety instructions can lead to unintended delivery of insulin).

2) Unscrew the cartridge cap, leaving the tubing connected to the cartridge.

3) With the tubing connected to the cartridge, pull the cartridge straight out of your insulin pump.

4) Disconnect tubing from cartridge, set the cartridge aside to return to Animas.

5) Fill a new cartridge from an unaffected lot not listed above, and attach infusion set tubing.

6) While still disconnected, rewind, load the cartridge and prime.

7) Connect tubing to site once prime is complete.

8)Fill cannula only if you have inserted a new infusion set.

Animas Customer Support can also be reached by phone toll-free at 877-937-7867.