Recall Z-0551-2016 ยท MEG Syringe, Antistick
Terumo Medical Corp
Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
| Date | Dec 24, 2015 (initiated Nov 23, 2015) |
| Status | Terminated |
| Reason | Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield). |
| Root cause | Process control |
| Action | 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. |
| Quantity | 80,500 units |
| Distribution | California |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) Terumo Europe N.V., Mar 18, 2014 |