The Arstasis One Access System, a type of arterial catheter that was originally recalled on October 19, 2010, has been heightened to a more serious recall by the FDA. The FDA has made the arterial catheter a Class 1 recall because of catheter malfunctions, like cracking or breaking. Class 1 recall are the most significant and dangerous type of recalls with a high probability of causing serious injury or death. Arterial catheters involved in the recall were circulated from May 14, 2010 to October 13, 2010. The recall affects two models of the product — AAD100 and AAD101 — and four lot numbers: 09I10268, 1OC26337, 09J06281, and 10C12334.

The company mailed recall letters to customers informing them of the recall and requesting they return the affected product for an “improved product” that did not have the breaking issue, an FDA statement said.

The device consists of a sheath/anchor, shaft, and handle with control features, the statement said.

The One Access System is used in femoral artery catheterization procedures and can be used with manual compression to help stop bleeding in the femoral artery, the statement said.

Primary Sources: http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/24802

The August egg recall is causing Miami cruise lines to double check their food inventory. Salmonella on egg shells has already sickened hundreds of people around the country and has been found in 13 retail brands. With hundreds of passengers onboard at one time, an outbreak of illness due to bad eggs could cause major problems.

Cruise ships — famous for endless buffets and generous meals — serve millions of eggs per year.

Royal Caribbean, for example, uses about 48.3 million eggs-worth of liquid egg product a year in the U.S. market, plus another 10.7 million fresh eggs. The company’s — and the world’s — largest cruise ship, Oasis of the Seas, uses about 32,000 whole eggs on an average weeklong cruise.

As the outbreak has forced the recall of more than half a billion eggs nationwide, the world’s two largest cruise lines — Miami-based Carnival Corp. and Royal Caribbean International — say their stock is free of the bacteria.

A spokeswoman for Norwegian Cruise Lines said no one was available to comment.

Primary Sources:

http://www.miamiherald.com/2010/08/28/1795952/cruise-lines-are-sailing-through.html