FDA Device recall Z-0551-2016
Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35 by Terumo Medical, citing potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0551-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-23 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Medical |
| Distribution | CA |
Product
Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
Reason
Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
Identifiers
| code_info | Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Terumo Medical
- GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box
FDA Device · Class II · 2026-08-19 · Terumo Medical - Terumo Needle, 30G x 1/2", Product Code NN3013R
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
FDA Device · Class II · 2019-07-31 · Terumo Medical - Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
FDA Device · Class II · 2019-07-31 · Terumo Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0551-2016%22
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