CLASS II ONGOING Device recall · Reported 3 Jan 2024 · FDA Enforcement Report
DeRoyal Cardiac Cath Set-up Kit Pgybk recalled by DeRoyal Industries
DeRoyal Industries is recalling DeRoyal Cardiac Cath Set-up Kit Pgybk, distributed in Virginia. The recall was initiated on 22 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0622-2024
- FDA event ID
- 93520
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2023
- FDA classified
- 28 Dec 2023
- Reported
- 3 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Nov 2023 | Recall initiated by company | |
| 28 Dec 2023 | Classified by FDA | +36 days |
| 3 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Product as listed by the FDA
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Where it was distributed
US: Virginia
Questions about this recall
Why was it recalled?
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Which lots are affected?
GTIN 00749756364065, Serial Numbers: '59716839, '59867186
Where was it sold?
US: Virginia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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