Class II

Medical Device Recall: DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

DeRoyal Industries Inc · November 22, 2023

Reason for Recall

Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

Distribution

US: Virginia

Quantity Affected

252 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0622-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

DeRoyal Industries Inc Medical Device Recall: DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 | SafeCheck