Class II — Terumo Medical Corporation
| Recalling firm | TERUMO MEDICAL CORP. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal. |
| Product | SurFlo IV Catheter |
| Quantity | 2,478,200 |
| Distribution | US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US. |
| Initiated | 2015-08-05 |
| Classified | 2017-05-01 |
| Terminated | 2017-05-01 |
| Recall number | Z-1896-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Terumo Medical Corporation (Z-1896-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76948/
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