Terumo Surflo Winged Infusion Set with Filter and Needle… recallZ-0551-2016 · Terumo Medical Corp · initiated Nov 23, 2015
Class II Terminated All recalls posted in December 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Medical Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0551-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 23, 2015
- Posted by the FDA
- Dec 24, 2015
- Recalling firm
- Terumo Medical Corp
- Quantity
- 80,500 units
- Product code
- MEG
- FDA submissions
- K133894
- Distribution
- California
Product description
Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
Code information (models, lots, serial numbers)
Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004.
Other devices under the same FDA submission
1 device cleared under K133894 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SURFLO™ SV-S25FL35Terumo Europe NV · Set, Administration, Intravascular1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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