Recall archive / FDA device enforcement
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 — FDA record Z-0622-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 22, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
- Reason
- Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
- Classification
- Class II
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 252 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0622-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 00749756364065, Serial Numbers: '59716839, '59867186 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: Virginia
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 3, 2024
- Recall initiation date
- Nov 22, 2023
- Center classification date
- Dec 28, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.