FDA Medical devices recall ·
smiths medical ProPort Plastic Venous Access System… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1280-2025
- Date
- (initiated February 13, 2025)
- Company / brand
- Smiths Medical ASD, Inc.
6000 Nathan Ln N, Minneapolis, MN, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 9506 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Worldwide distribution.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1280-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.