Recall archive / FDA device enforcement
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose dr... — FDA record Z-3147-2024
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 APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
- 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
- 89 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3147-2024
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) GTIN/UDI 0871472932347, Lot # 33540319, Exp. 03/01/2027; b) GTIN/UDI 0871472932348, Lot # 33471466, Exp. 02/21/2027 |
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.