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The Dose

Welcome to The Dose, which tackles the business and economics inside the turbulent world of health care and life sciences in Indiana. Your host is John Russell. To contact me call 317-472-5383.
Health Care Businesses

Cook Medical issues fourth recall in 18 months

February 15, 2016

It’s been a tough year or so for product recalls at Cook Medical, the Bloomington maker of devices ranging from needles to incubators.

In the past 18 months, Cook has issued four recalls covering more than 100,000 devices, according to the FDA product recall website. Several of them have been linked to customer complaints and required medical intervention.

The most recent one occurred on Feb. 10, when Cook recalled 17,827 venous catheters and pressure monitoring sets and trays from 360 lots due to the potential for fracture or separation of the catheter tips. The products are used in venous or arterial pressure monitoring, blood sampling and administration of drugs and fluids.

The company said it found the problem during an internal inspection, and traced it to the technique of a product assembler. No reports of illness or injury were linked to the products, but potentially, a separated tip could block blood flow to organs, leading to possible stroke, kidney injury or damage to the intestines or limbs, the company said in its recall notice.

A company spokeswoman said Monday the recalls were relatively small compared to its annual production of 32 million products.

“When our system is working correctly, as it did in this case, we identify the potential problem and issue a recall,” Cook Medical spokeswoman Moriah Sowders wrote in an email. “Product recalls are a tool we use to notify customers so they can return the product. This recall impacted a small percentage of our products (.05 percent), but we want to make every effort to hasten the return of recalled products and minimize potential risk.”

The latest recall comes as Cook is dealing with a deluge of product lawsuits claiming the company’s medical devices harmed them. Patients from around the country have filed 100 lawsuits, alleging that some of its blood-clot filters have broken apart, sometimes requiring medical procedures to remove them. The suits were consolidated last year in federal court in Indianapolis.

Previous recalls with Cook products include 95,156 angiographic catheters in 2015, linked to 26 complaints and 14 medical device reports; and 696 vascular retrieval snare devices in 2014, which required medical intervention in four cases, linked to 42 medical device reports.
 

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