Recall archive / FDA device enforcement
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 — FDA record Z-0202-2023
Reported terminated
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 Aug 19, 2022. 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
- MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
- Reason
- Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.
- Classification
- Class III
- Recalling firm
- Canadian Hospital Specialties
- Quantity
- 9100 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0202-2023
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: 00628725001050, Lot Numbers: 159603, exp 2026-12-01 and 166945, exp 2027-06-01 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 23, 2022
- Recall initiation date
- Aug 19, 2022
- Center classification date
- Nov 11, 2022
- Termination date
- Mar 20, 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.