Recall Z-0551-2016— Terumo Medical Corp
Class II · Terminated
Class II FDA medical device recall by Terumo Medical Corp, initiated 2015-11-23, terminated 2017-08-01. It names one FDA 510(k) clearance: K133894. Product: Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.. Reason: Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)..
- Recalling firm
- Terumo Medical Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-23
- Terminated
- 2017-08-01
- Firm location
- Somerset, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
Reason for recall
Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
Data sourced from openFDA. This site is unofficial and independent of the FDA.