384,000 J&J Animas Insulin Pump Cartridges Recalled

Injuries Reported; Firm Says It's Contacting Users

By Daniel J. DeNoon
WebMD Health News

Reviewed By Laura J. Martin, MD

March 9, 2011 -- Johnson & Johnson has recalled about 384,000 of its Animas Insulin Pump cartridges in the U.S. and France.

According to Reuters, J&J has received 22 injury reports so far.

The cartridges may leak at the plunger side of the cartridge. If this happens, users may receive too little insulin.

The results could be fatal. Diabetes patients who get too little insulin can develop diabetic ketoacidosis. Symptoms include nausea, vomiting, shortness of breath, and excessive thirst and urination. If people with diabetes develop these symptoms, they should seek immediate medical care.

The recall was posted on J&J's Animas web site on Feb. 24. Reuters and Dow Jones Newswire first reported the recall on March 8. According to a message on J&J's Animas web site marked "urgent," the company is contacting every pump user that might have received the recalled cartridges.

Only specific lots of the cartridges are affected. The lot number is clearly marked on the product label. Recalled lot numbers are:

• B201575
• B201576
• B201581
• B201582
• B201583

Patients using recalled cartridges should immediately disconnect the infusion set by following these instructions, as provided by Animas:

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 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.

J&J says replacement cartridges have been shipped to users and should have been received by March 2. Users who have not received replacements may call 877-280-2339.

SOURCES: Johnson & Johnson Animas web site.Wall Street Journal.Reuters.

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