Recall archive / FDA device enforcement
Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 — FDA record Z-1796-2024
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 I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
- Reason
- Potential for unsealed sterile packing.
- Classification
- Class II
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 7935 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1796-2024
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 00613994575319, Lot Numbers: 2023041320, 2023041323; GTIN 00673978180465, Lot Numbers: 2023041316, 2023041323; GTIN 20613994575313, Lot Numbers: 2023041316, 2023041318, 2023041320, 2023041323, 202305C146, 202305C154 |
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.