DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
- Company
- Deroyal Industries Inc
- Recall Initiated
- November 22, 2023
- Posted
- September 30, 2024
- Recall Number
- Z-0622-2024
- Quantity
- 252 units
- Firm Location
- Powell, TN
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
US: Virginia
Lot / Code Info
GTIN 00749756364065, Serial Numbers: '59716839, '59867186
Root Cause
Device Design
Action Taken
DeRoyal Industries issued am URGENT FIELD CORRECTIVE ACTION notice to its sole consignee on 11/22/2023 via email. The notice explained the issue and provided instructions on the proper use of the device.
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