Device product
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Z-0622-2024
Product summary
- Event
- Event 93520
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 252 units
- Official record key
device-enforcement:Z-0622-2024
Official wording
Reason: Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Code information: GTIN 00749756364065, Serial Numbers: '59716839, '59867186
Distribution pattern: US: Virginia
Derived failure modes
-
Unknown
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.