FDA announces recall of dangerous arterial catheters
The U.S. Food and Drug Administration (FDA) has announced a recall by Medline Industries, affecting its Integrated Arterial Catheter products. The issue stems from a manufacturing error that caused excess material to be present on the catheter hub. If used, the unwanted material could potentially enter a patient’s bloodstream.
The recall affects several kits, bundles, and insertion trays manufactured by Medline. The arterial catheters are used to continuously monitor blood pressure and take blood samples from patients. While there have been no reported injuries, due to a risk of catastrophic adverse effects, including the blockage of blood vessels leading to death, the recall has been designated as Class I, the most serious type.
What is being recalled?
Catheters with the following names, Unique Device Identifier (UDI) and item numbers subject to the recall:
- ARTERIAL LINE INSERTION KIT, Item Number ART1185B/10653160379225
- ARTERIAL LINE BUNDLE, Item Number ART255/10653160367598
- ARTERIAL LINE TRAY, Item Number ART350/10653160362050
- ARTERIAL LINE BUNDLE, Item Number ART355/10653160361817
- ARTERIAL LINE BUNDLE, Item Number ART355/10653160361817
- ARTERIAL LINE INSERTION TRAY, Item Number ART475/10653160367659
- ARTERIAL LINE BUNDLE - OR, Item Number ART535A/10653160367604
- ARTERIAL LINE TRAY, Item Number ART545A/10653160375135
- ARTERIAL LINE INSERTION KIT, Item Number ART775C/10653160366102
- ARTERIAL LINE TRAY, Item Number ART840/10653160366966
- ARTERIAL LINE KIT, Item Number ART890B/10653160360834
- ARTERIAL LINE TRAY, Item Number ART600/10653160312727
- ARTERIAL LINE TRAY, Item Number ART690/10653160318019
Next Steps
If any healthcare organization is in possession of any of the arterial catheters or associated devices subject to the recall, they must immediately stop using them. Medline and the FDA have asked providers and suppliers to do a stock check to ensure potentially defective products are quarantined.
If recalled products are removed, the remainder of the kit may still be used.
All affected customers should complete the response for, which can be found here, using reference number R-24-278-FGX1. Known customers were sent a notice from Medline on Dec. 31, 2024, which contained a recall code to include with the response form.
For more details, read the full FDA notice here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.