Z-0551-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2015
- Initiation Date
- November 23, 2015
- Termination Date
- August 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80,500 units
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).
Distribution Pattern
California
Code Information
Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004.