Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
This recall has been terminated (originally issued December 24, 2015).
- Company
- Terumo Medical Corp
- Recall Initiated
- November 23, 2015
- Posted
- December 24, 2015
- Terminated
- August 1, 2017
- Recall Number
- Z-0551-2016
- Quantity
- 80,500 units
- Firm Location
- Somerset, NJ
- Official Source
- View on FDA website ↗
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
California
Lot / Code Info
Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004.
Root Cause
Process control
Action Taken
Terumo N.V. Europe notified their US Importer (Termumo Medical Corporation, Somerset, NJ) of the voluntary recall on 11/23/2015 via phone and email. Terumo Medical Corporation in turn notified their sole consignee on 11/24/2015 by email that included the manufacturers Recall Notification. The notification informed the customer of the reason for the recall; how to identify affected product; to immediately identify and quarantine any available stock; and complete and return the attached Reply Form.