FDA recall Z-0622-2024

DeRoyal Industries Inc · Class II · device

Product

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.

Distribution

US: Virginia

Key facts

Status: Ongoing
Initiation date: 2023-11-22
Report date: 2024-01-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0622-2024