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
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