FDA-Device2018-04-11Class II
Radial Artery Catheterization Kit; Model: AK-04220
Arrow International Inc
Hazard
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Sold states
US nationwide distribution, including Puerto Rico.
Affected count
6358
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
Radial Artery Catheterization Kit; Model: AK-04220
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1286-2018Don't want to check this manually?
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