FDA shares warning about cath lab procedure kits due to risk of patient injury
The U.S. Food and Drug Administration (FDA) has shared new details about an ongoing safety issue with millions of Medline syringes.
The agency previously announced a Class I recall of certain NAMIC angiographic control syringes. The devices, used by cardiologists and radiologists to administer radiographic contrast media, were recalled due to a risk of a “loose connection and/or full disconnection” during use. Four serious patient injuries have been linked to this issue.
Now, the FDA is highlighting the fact that these same Medline syringes are included in several procedure kits sold by Virginia-based AVID Medical. This includes the company’s Cardiac Cath Pack, Heart Cath, Self Regional, Cath Lab and Neuro IR Peripheral convenience kits.
Any companies that sell and distribute these convenience kits have been told to add warning labels as needed that say the syringes “must be removed and discarded from further use.”
“Use the labeling template provided by AVID to print labels,” according to the FDA’s advisory. “This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling.”
If customers must use one of these syringes because no other devices are available, the FDA added, it should be done with “extreme caution and vigilance.”
Read the FDA’s early alert in full here. For additional context about this issue, click here.
More information to come
This early alert from the FDA is intended to help keep the public informed about potential safety issues while they are still under investigation. Read more about that program here.
Cardiovascular Business will continue to monitor this story.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.