DeRoyal recalls CARDIAC CATH SET-UP KIT PGYBK with Edwards Life Sciences TruWave disposable pressure transducers that were previously recalled. Affected units have specific serial numbers and GTIN.
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
DeRoyal is recalling its CARDIAC CATH SET-UP KIT PGYBK model because it includes pressure transducers previously recalled by Edwards Life Sciences. This means the kit may have faulty components that could pose safety risks if used improperly.
The kit includes Edwards Life Sciences TruWave disposable pressure transducers that were previously recalled by Edwards. These transducers may have manufacturing defects that could lead to inaccurate readings or other issues during medical procedures.
Medical professionals using the DeRoyal CARDIAC CATH SET-UP KIT PGY: 1. Users with the specific serial numbers listed (59716839, 59867186) or GTIN 00749756364065 are affected. 2. Those using the kit for medical procedures may be at risk if the transducers are defective.
Check for the model number 'CARDIAC CATH SET-UP KIT PGYBK' with serial numbers '59716839' or '59867186' and GTIN 00749756364065. The product was sold with these specific identifiers.
Verify the serial numbers and GTIN to confirm if your kit is affected.
The kit includes Edwards Life Sciences TruWave disposable pressure transducers that were previously recalled by Edwards Life Sciences due to manufacturing defects.
Check the serial numbers and GTIN to see if your kit is affected; if so, contact DeRoyal for further instructions.
The kit may have faulty transducers that could lead to inaccurate readings during medical procedures, but no specific safety risks are stated in the recall notice.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0622-2024 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0622-2024 from DeRoyal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
