The Class I recall is just the latest in a series of catheter recalls for U.S. companies.
A Michigan company is recalling certain single-lumen catheters due to the potential for excess material to separate from the catheter and enter a patient’s bloodstream.
|Don't miss the MD&M West conference and expo, February 7–9, 2016.|
Centurion Medical Products of Williamston, MI, initiated the recall of 1000 Centurion Convenience Kits containing its Multi-Med single-lumen catheters, FDA announced in the Class I recall notice. The kits were distributed in the U.S. between May 23 and October 18, 2016, and are marked with the codes ECVC1680, ECVC4785, M11620HKIC, M11620HKICNL, M11620HS, M11620KC, M11620KCNL, M12013K, and M12013KNL.
The central venous catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process, according to FDA. If this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.
The agency did not reveal whether any patients were harmed by the Centurion catheters. A review of adverse event reports related to Centurion products revealed one instance in which a patient suffered atrial fibrillation possibly related to a cracked catheter with a different model number, but no reports on the recalled product.
The company notified customers in October of the voluntary recall. A list of the affected lot numbers can be found on the FDA website. Centurion did not respond to requests for comment.
Other manufacturers’ catheters have been subject to several previous recalls due to the potential for materials breaking off the devices and entering a patient’s bloodstream.
FDA cited a similar danger from the manufacturing process in a September recall of nearly 16,000 catheters made by Vascular Solutions of Maple Grove, MN. Nearly 6,000 of the recalled Twin-Pass catheters were distributed in the United States between October 2014 and September 2016.
The largest such recall in 2016 involved Cook Medical, which voluntarily recalled all of its catheters with Beacon Tip technology—about 4.1 million units globally—in April because of complaints of the tips splitting or fracturing during procedures. That recall expanded on a much smaller 2015 recall that involved 95,167 devices. Officials of the Bloomington, IN, company said they recalled all lots to assure patient safety.
Nancy Crotti is a contributor to Qmed.
[image courtesy of IDEA GO/FREEDIGITALPHOTOS.NET]
- Drowning in Big Data: Extracting Medical Device Quality and Safety Insights - Webcast
- Quality with Confidence – What You Need to Know About Digital Microscopes for Medical Device Quality Processes - Webcast
- Risk Management for Medical Device Manufacturers - Webcast
- 3 Steps for Designing the Ideal Medical Device Packaging System - Webcast
- Reducing Device Cost with Innovative Medical Materials - Webcast
- Automating your Quality Management System: Pitfalls & Essentials - Webcast