Recall archive / FDA device enforcement
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit — FDA record Z-1173-2025
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 Jan 3, 2025. 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
- Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
- Reason
- Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 36 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1173-2025
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 | UDI/DI 10193489736755 (ea) 40193489736756 (cs), Lot Numbers: 22HLA247, 21HLA443, 21JLA520, 22GLA335. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: CA
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
- Feb 26, 2025
- Recall initiation date
- Jan 3, 2025
- Center classification date
- Feb 14, 2025
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.