FDA Device recall Z-1277-2025
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
- FDA Device
- Class I
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class I recall of smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24 by Smiths Medical Asd, citing the plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1277-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-13 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Reason
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Identifiers
| code_info | UDI/DI 10610586012518, Lot Number 4235595 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1277-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.