Reported Jan 3, 2024 · Ongoing
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
- Lot codes and dates
- GTIN 00749756364065
- Serial Numbers
'59716839'59867186
- Amount recalled
- 252 units
Where it was sold
Why it was recalled
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
This product could cause temporary or reversible health problems — stop using it.
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