FDAClass IIJanuary 3, 2024

Deroyal Cardiac Cath Set-up KIT Pgybk recall

DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

Why was Deroyal Cardiac Cath Set-up KIT Pgybk recalled?

Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN 00749756364065, Serial Numbers: '59716839, '59867186

Product
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Recalling firm
DeRoyal Industries Inc
Quantity
252 units
Distribution
US: Virginia
Recall date
January 3, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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