DeRoyal Cardiac Cath Kit Recalled for Defective Pressure Transducers
DeRoyal Industries is recalling a cardiac catheterization kit that contains Edwards Life Sciences pressure transducers that were subject to a separate recall by their manufacturer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a recalled component that poses risk of harm in cardiac procedures. No illnesses or injuries have been reported in the source material, but the hazard involves a critical medical device component.
Plain-English summary
DeRoyal Industries Inc is recalling the DeRoyal CARDIAC CATH SET-UP KIT PGYBK (REF 89-10572). The kit was manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers, which were subsequently recalled by Edwards Life Sciences.
252 units of this kit were distributed in Virginia. The pressure transducers are critical components used during cardiac catheterization procedures and their defect could impact the safety and function of the procedure.
The recalled product
- Product
- DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 252
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN 00749756364065
- Serial Numbers: '59716839
- '59867186
Distribution
Distributed in 1 state:
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