Medical Device Recall Issued For Surgical Stapler Sets
New Jersey residents may want to stay informed on the status of a more recent medical product recall. Popular manufacturer Johnson & Johnson has been issued another medical device recall. Reports indicate that more than 150,000 stapler devices have been recalled following the discovery of potentially fatal health risks.
The products, Proximate PPH hemorrhoidal circular stapler, Proximate HCS hemorrhoidal stapler and Transtar circular stapler procedure set are all subject to the recall. The devices are considered defective and the U.S. Food and Drug Administration is concerned over the risk of serious health risks, including possibly death. The recall has been listed as a Class 1, the most serious classification used by the FDA.
The recall states that the devices are difficult to fire, which can cause incomplete staple formation. The FDA says that may cause bleeding and sepsis as well as pain, occlusion and dysfunction. Distributors and customers are urged to stop using the recalled devices and contact Johnson & Johnson. The recalled products were distributed between April 2011 and July 2012. According to Johnson & Johnson, the problems with the products arose as the result of a change in a lubrication process.
Treatment of conditions such as hemorrhoids is quite common. Surgical treatment is less common, and advances such as surgical staples are usually welcome. But as this recall suggests, advances can bring with them risks if a product used is unsafe. Complications from surgery, for whatever reason, can cause serious health risks for the patient. They may also cause severe anxiety and additional medical expenses. Sometimes they can cause fatalities.
Anyone in New Jersey who believes that they have been injured due to a faulty medical device or drug should contact their care provider immediately. At the same time, they should contact an experienced attorney.
Source: Wall St. Cheat Sheet, “Oops! Johnson & Johnson Forced to Recall This Dangerous Product,” Martin Armstrong, Nov. 3, 2012