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-1279-2025
- 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
- 2311 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
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 10610586012549, Lot Numbers: 3928188, 3953708, 3957301, 3968097, 3977434, 3988450, 4006475, 4022600, 4027912, 4036893, 4073108, 4086999, 4103105, 4114110, 4122783, 4136362, 4139518, 4152689, 4153871, 4173433, 4189866, 4222392, 4227822, 4235597, 4276226, 4307472, 4317085, 4349806, 4378522, 4387732, 4395511, 4460618, 4434228, 4449233, 4449875, 6013082, 6014983, 4468606, 4426417, 6062037, 6071256.
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-1279-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.