Z-0551-2016Class II

Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)

Name: Z-0551-2016 Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)
Creator: Terumo Medical Corp
Published: 2015-11-23
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2015-11-23 / Terminated / root cause: manufacturing process

FDA source

Terumo Medical Corp began a recall of Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35 on 2015-11-23. FDA classified it as Class II and gives the reason as "Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0551-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-23
Posted: 2015-12-24
Terminated: 2017-08-01
Recalling firm: Terumo Medical Corp.
Product: Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
Product code: MEG Syringe, Antistick
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).
Root cause tag: manufacturing process
FDA 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 in commerce: 80,500 units
Distribution: California
Product codes and lots: Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0551-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0551-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24

Product code MEG

K133894Class IISurflo Winged Infusion Set with Filter & Needle Protection (Surshield)Terumo Europe N.V. / cleared 2014-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)