CLASS I ONGOING Device recall · Reported 26 Mar 2025 · FDA Enforcement Report
smiths medical ProPort Plastic Venous Access System recalled
Smiths Medical ASD is recalling smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.) O.D. x. The recall was initiated on 13 Feb 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1283-2025
- FDA event ID
- 96294
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 13 Feb 2025
- FDA classified
- 18 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 13 Feb 2025 | Recall initiated by company | |
| 18 Mar 2025 | Classified by FDA | +33 days |
| 26 Mar 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Which lots are affected?
UDI/DI 10610586012716, Lot Numbers: 3941279, 3969275, 3984421, 4022601, 4136364, 4148590, 4153873, 4196768, 4227788, 4232310, 4235600, 4248718, 4276227, 4302980, 4307478, 4317093, 4325880, 4358053, 4358054, 4395512, 4415445, 4420760, 4437255, 4449234, 4449877, 4460620, 6013083, 6003891, 6053532, 6062026.
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 96294This product is part of a recall event; the main page for the event is smiths medical ProPort Plastic Venous Access System recalled.
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