FDAFDA · Food and drugs·Recall number Z-0622-2024
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Published January 3, 2024 · Recall initiated: November 22, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- US: Virginia
- Lot
- GTIN 00749756364065, Serial Numbers: '59716839, '59867186
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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