Recall archive / FDA device enforcement
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of... — FDA record Z-3149-2024
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 Jul 18, 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
- Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
- Reason
- There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
- Classification
- Class II
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 10 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3149-2024
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/UDI 0871472932337, Lot # 33550953, exp. 03/04/2027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US, Colombia, Philippines, Russia
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 25, 2024
- Recall initiation date
- Jul 18, 2024
- Center classification date
- Sep 13, 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.