[Recalled] Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35. — Potential improper bonding between the tube and luer for certain lots of Surflo… | FDA 2015-11-23
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35. |
|---|---|
| Brand / manufacturer | Terumo Medical Corp |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0551-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 23 November 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Terumo Medical Corp
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.