Device recall
Z-1287-2025: smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow…
FDA device recall · Class I · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-1287-2025 |
|---|---|
| Recall event | 96294 |
| Product | smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24 |
| Product code | LJT |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K994216 |
| FEI number | 3012307300 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database