Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
FDA device recall Z-0551-2016 · posted 2015-12-24 · Terminated
Recall details
- Recalling firm
- Terumo Medical Corp
- 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).
- Action taken
- 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
- Status
- Terminated
- Product code
- MEG
- Quantity affected
- 80,500 units
- Distribution
- California
- Date initiated
- 2015-11-23
- Date posted
- 2015-12-24
- Date terminated
- 2017-08-01
- Location
- Somerset, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) (K133894) | Terumo Europe N.V. | 2014-03-18 |