Hemorrhoid Surgical Stapler Recalled
Johnson & Johnson Ethicon Endo-Surgery division has recalled more than 157,000 stapling devices and related accessories used to treat hemorrhoids. The FDA upgraded the recall to a Class 1 due to the severity of the associated injuries.
About the Products
- Three types of staplers have been recalled.
- One product is called the Proximate HCS hemorrhoidal circular stapler. The stapler and its accessories have the product code “PPH01” printed on them.
- The Proximate PPH hemorrhoidal circular stapler and accessories were also recalled.
- The Transtar circular stapler procedure set was also recalled.
- In addition, Johnson & Johnson has discontinued the HCS stapler in the United States.
Damage from Staplers Can Be Severe
This is an extremely serious recall, says the FDA, and injury caused by the devices could result in serious issues, including sepsis and death. Potential complications include: sepsis (which can lead to death), severe pain, bleeding, and serious rectal damage.
Recall Due to Maunufacturing Error
- The cause of the misfiring is a change in the manufacturing lubrication process that was implemented in April 2011. This change could impact the devices' force-to-fire.
- The stapling device is used to clamp down on hemorrhoids to cut off blood flow to then, which would get rid of the hemorrhoid.
- The problem is the stapling process itself. The stapler may not complete its firing process, resulting in an incomplete staple formation.
Distribution of Product
The product was made and distributed between April of 2011 and June of 2012. All individuals and retailers in possession of this product should immediately discontinue use and/ or sale of this product. Johnson and Johnson, the manufacturer of the product, can be reached through its website, https://secure-www.jnj.com/wps/wcm/jsp/contactUs.jsp, or by phone at (732) 524-0400.
Contact an Experienced Product Liability Attorney
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