Recall archive / FDA device enforcement
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x... — FDA record Z-1287-2025
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 Feb 13, 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
- smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
- Reason
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Classification
- Class I
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 8515 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1287-2025
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 10610586012778, Lot Numbers: 3916028, 3969277, 4006477, 4022602, 4036895, 4057818, 4060894, 4096338, 4108453, 4114117, 4146468, 4153874, 4163556, 4196775, 4221727, 4235565, 4235567, 4235601, 4248694, 4256927, 4256928, 4256964, 4276228, 4294894, 4294895, 4364693, 4366695, 4366696, 4378523, 4382349, 4392370, 4395513, 4405010, 4420761, 4426418, 4434230, 4453606, 4468579, 4468580, 6005957, 6005958, 6026650, 6026651, 6037122, 6037124, 6051325. |
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
- Mar 26, 2025
- Recall initiation date
- Feb 13, 2025
- Center classification date
- Mar 18, 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.