Radial Artery Catherization Set with Integral Needle Protection, Model Ra-04020-Sp

• • Ongoing Z-2377-2026 FDA Class I ·initiated 21 Apr 2026

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

• • Terminated Z-1973-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

510(k) Number

K021120 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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