smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6F
Summary
The FDA issued a Class I for smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Cathe by Smiths Medical ASD, Inc.. Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect..
Details
Source
Device Recall
External ID
Z-1280-2025
Action Date
2025-03-26
Status
Ongoing
Category
device
Product Description
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
Lot/Code Info: UDI/DI 10610586012563, Lot Numbers: 3926121, 3928189, 3953709, 3957303, 4006476, 4008521, 4036894, 4046803, 4096337, 4108664, 4114114, 4114115, 4136363, 4146466, 4153872, 4173601, 4232305, 4235508, 4235598, 4271453, 4291483, 4294059, 4317075, 4317092, 4358052, 4366693, 4366694, 4387733, 4434229, 4449244, 4453603, 4453604, 4453605, 6001912, 6026649, 6051324, 6062012, 6071257, 6077416.
Quantity Affected: 9506 units
Reason for Recall
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-13
Company
Minneapolis, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smiths Medical ASD, Inc. has 164 FDA actions in our database, including 162 recalls and 2 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smiths Medical ASD, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smiths Medical ASD, Inc. have FDA actions?
Smiths Medical ASD, Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1280-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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