FDA Medical Device Recalls (openFDA)
Terumo Medical Corp: Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
- Recall number
- Z-0551-2016
- Recalling firm
- Terumo Medical Corp
- Product
- Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
- Status
- Terminated
- Initiated
- 2015-11-23
- Posted
- 2015-12-24
- Terminated
- 2017-08-01
- 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
- Lot, serial or model codes
- Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004.
- 510(k) numbers
- ["K133894"]
- PMA numbers
- not on file
- Product code
- MEG
- Firm FEI
- 2243441
- Firm city
- Somerset
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28