Updated November 9, 2012, at 3 p.m. with additional comments from Baxter.
Baxter (NYSE:BAX) issued an urgent product recall covering 9 years’ worth of its Clearlink and Interlink buretrol solution sets over concerns that the devices "may cause serious adverse health consequences, including death."
The buretrol systems are disposable IV pathways and are used to administer fluids to a patient’s bloodstream by connecting to a vascular access device. The product line is a small one for Baxter, and the company has alternative buretrol solutions sets available for customers, company spokesman Bill Rader told MassDevice.com today.
Baxter recalled the devices after receiving complaints that air was traveling below the ball-valve into the drip chamber and then into the tubing. If air passes through the tubing and into a patient’s bloodstream it could result in a potentially dangerous air embolism, according to an FDA warning.
No patient injuries or adverse events as a result of the ball-valve defect have been reported, according to Baxter. The tubing can be re-primed between uses to remove air bubbles, but that may delay therapy, according to Baxter’s September warning letter. Failure to remove the air bubbles, however, may pose a risk to patients.
The recall, originally initiated September 7, 2012, and posted by the FDA this week, includes all lots of Baxter’s Interlink and Clearlink buretrol solutions sets with 150 mL burettes.
The recall affects devices distributed over a period of more than 9 years, from May 2003 to August 2012, and is "well underway," according to Baxter. There are nearly 2 million affected units in distribution and the devices were distributed in the U.S., Canada, Costa Rica, Australia, New Zealand, Hong Kong and the U.K., according to an FDA enforcement report released last month.
Most customers don’t keep the buretrol devices in inventory for more than a few months, so the 2 million figure provided by the FDA likely doesn’t reflect that number of devices currently on shelves, Baxter representatives told us. Given the 9-year time frame of the recall, there’s a "low likelihood" that the older products are still in circulation, the company said.
The FDA slapped the recall with Class I status, a label that designates "the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
Customers were asked to stop using the affected Clearlink and Interlink systems and to contact Baxter for instructions on how to return them.
This marks the 2nd recall for Baxter in recent months. In August the FDA gave Class I status to Baxter’s decision to pull all Automix nutrition compounding systems in the U.S. over concerns that the devices could fail and deliver dangerous and potentially fatal chemical doses to patients.