DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Reported: January 3, 2024 Initiated: November 22, 2023 #Z-0622-2024
Product Description
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.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 252 units
- Distribution
- US: Virginia
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572. Recalled by DeRoyal Industries Inc. Units affected: 252 units.
Why was this product recalled? ▼
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 3, 2024. Severity: Moderate. Recall number: Z-0622-2024.
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