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, Pre-assembled with PolyFlow. The recall was initiated on 13 Feb 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI/DI 10610586012686, Lot Numbers: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, 6003890.

Quantity recalled1695 units

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-1282-2025
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, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24

Where it was distributed

Worldwide distribution.

Questions about this recall

Is smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow recalled?

Yes. Smiths Medical ASD recalled smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow on 13 Feb 2025. The recall is Class I and its status is Ongoing. Recall number Z-1282-2025.

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 10610586012686, Lot Numbers: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, 6003890.

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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