DeRoyal Industries Inc. is recalling 252 units of its Cardiac Cath Set-Up Kit PGYBK (Model REF 89-10572) because they contain Edwards Life Sciences TruWave disposable pressure transducers that were previously recalled by their original manufacturer. These kits, used during heart procedures, were distributed in Virginia and were manufactured in the United States. Consumers should contact their healthcare provider or DeRoyal Industries to determine if their kit is affected and to receive further instructions.
The included pressure transducers may be defective, which can lead to inaccurate blood pressure readings or compromised sterile barriers during sensitive cardiac procedures. This poses a moderate risk of patient injury if medical decisions are made based on incorrect data or if an infection occurs.
Manufacturer notification and guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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