smiths medical ProPort Plastic Venous Access System — Class I medical device recall Z-1279-2025
Ongoing recall by Smiths Medical ASD, Inc., reported 2025-03-26. The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a
| Recall number | Z-1279-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Minneapolis, MN, United States |
| Recall initiated | 2025-02-13 |
| Classified | 2025-03-18 |
| Reported by FDA | 2025-03-26 |
| Quantity | 2,311 units |
| UPC / GTIN / 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, 4426417, 4434228, 4449233, 4449875, 4460618, 4468606, 6013082, 6014983, 6062037 and 1 more |
| Model numbers | 21-4152-24 |
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
Reason for recall
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1279-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.