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Terminated

Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.

FDA Recall Z-0551-2016 · Posted 2015-12-24

Recalling FirmTerumo Medical Corp
Recall StatusTerminated
Product CodeMEG
Date Initiated2015-11-23
Date Terminated2017-08-01
Product Quantity80,500 units

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).

Firm 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.

Root Cause

Process control

Distribution Pattern

California

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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