FDA-Device2020-01-29Class II
Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.
Arrow International Inc
Hazard
The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
Sold states
US distribution to SC
Affected count
80 eaches
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide Product Code: ASK-04020-PMC The Arrow¿ Arterial Catheterization 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-0844-2020Don't want to check this manually?
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