FDA-Device2024-01-03Class II
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
DeRoyal Industries Inc
Hazard
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Sold states
US: Virginia
Affected count
252 units
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0622-2024Don't want to check this manually?
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