FDA-Device2018-02-21Class II
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Hazard
Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Sold states
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Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0486-2018Don't want to check this manually?
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