FDA designates recall of radial artery and arterial line catheterization kits as class I
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Key takeaways:
- The FDA designated the recall of radial artery and arterial line catheterization kits as class I, the most serious type.
- Affected kits may cause injury to the vessel wall, vasospasm, embolism or death.
Arrow International, a subsidiary of Teleflex, has issued a recall of its radial artery and arterial line catheterization kits due to increased resistance that may cause injury to the vessel wall, vasospasm, embolism or death.
The FDA has identified the recall of the catheterization kits (Arrow QuickFlash) as a class I recall, the most serious type of recall, as use of the device may cause serious injury or death.
The recall includes 334,995 devices distributed from December 2021 to Jan. 27.
There have been 194 complaints, 10 injuries and one death related to the issue, according to a press release from the FDA.