FDA Device recall Z-1282-2025
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.…
- FDA Device
- Class I
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class I recall of smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.… by Smiths Medical Asd, citing the plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1282-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-13 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Reason
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Identifiers
| code_info | UDI/DI 10610586012686, Lot Numbers: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4…UDI/DI 10610586012686, Lot Numbers: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, 6003890. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1282-2025%22
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