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 | Medical devices were incorrectly labeled with extended expiration dates. |
| Product | Pinnacle® Destination® Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature. |
| Quantity | 20 units |
| Distribution | Nationwide Distribution. |
| Initiated | 2013-05-30 |
| Classified | 2013-06-27 |
| Terminated | 2013-10-30 |
| Recall number | Z-1611-2013 |
| 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-1611-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65397/
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