Recall archive / FDA device enforcement
Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), M... — FDA record Z-1802-2024
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 Mar 19, 2024. 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
- Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
- Reason
- Potential for unsealed sterile packing.
- Classification
- Class II
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 1624 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1802-2024
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 | a) Model Number 61000, GTIN 00643169880955, Lot Numbers: 2023030432, 2023030433; a) Model Number 61000, GTIN 20643169880959, Lot Numbers: 2023030431, 2023030432, 2023030433, 2023030734, 202305C226, 202307C176, 202307C177; b) Model Number 62000, GTIN 20613994846642, Lot Numbers: 2023030223, 2023030736, 2023031580, 202305C225 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 22, 2024
- Recall initiation date
- Mar 19, 2024
- Center classification date
- May 10, 2024
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.