Terumo Recalls Winged Infusion Sets Due to Improper Bonding
Terumo Medical Corp is recalling 80,500 units of Surflo Winged Infusion Sets distributed in California due to potential improper bonding between the tube and luer.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (improper bonding) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Medical Corp is recalling 80,500 units of the Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code SV-S25FL35. The affected lots are 1508023, 1509011, and 1510004. These products were distributed in California.
The recall is being conducted because of potential improper bonding between the tube and the luer. This defect could compromise the integrity of the infusion set during use.
Healthcare providers and facilities that have received these specific lots should stop using them and contact Terumo Medical Corp for instructions on return or replacement. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
- Manufacturer
- Terumo Medical Corp
- Category
- Medical Device — Infusion Sets
- Affected units
- 80,500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: SV-S25FL35 Lot Numbers 1508023
- 1509011 and 1510004.
Distribution
Distributed in 1 state:
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