Z-0622-2024 Class II Ongoing
FDA device recall Z-0622-2024 was initiated by DeRoyal Industries Inc on November 22, 2023 and is designated Class II. Reason for recall: Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences. The recall status is ongoing. Affected quantity: 252 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 3, 2024
- Initiation Date
- November 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 252 units
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.
Distribution Pattern
US: Virginia
Code Information
GTIN 00749756364065, Serial Numbers: '59716839, '59867186