DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
FDA Recall #Z-0622-2024 — Class II — November 22, 2023
Product Description
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Reason for Recall
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Recalling Firm
DeRoyal Industries Inc — Powell, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
252 units
Distribution
US: Virginia
Code Information
GTIN 00749756364065, Serial Numbers: '59716839, '59867186
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated