Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introduc...
FDA Recall #Z-0844-2020 — Class II — December 12, 2019
Product Description
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.
Reason for Recall
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
Recalling Firm
Arrow International Inc — Reading, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
80 eaches
Distribution
US distribution to SC
Code Information
Lot/Batch Number: PMC 23F19H0224
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated