DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 recallZ-0622-2024 · DeRoyal Industries Inc · initiated Nov 22, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0622-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 22, 2023
- Posted by the FDA
- Sep 30, 2024
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 252 units
- Product code
- LRO
- FDA submissions
- K842648
- Distribution
- US: Virginia
Product description
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Code information (models, lots, serial numbers)
GTIN 00749756364065, Serial Numbers: '59716839, '59867186
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal 89-10572Deroyal Industries, Inc. · General surgery tray1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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