Drug recall
Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a…
FDA recall event 65397 · Class II · Terumo Medical Corporation
Key facts
| Event ID | 65397 |
|---|---|
| Recall numbers | Z-1611-2013, Z-1612-2013 |
| Recalling firm | Terumo Medical Corporation |
| Product type | Devices |
| Products | 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…, Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medical devices were incorrectly labeled with extended expiration dates. |
| Initiation date | May 30, 2013 |
| Report date | Jul 3, 2013 |
| Termination date | Oct 30, 2013 |
| City | Elkton |
| State | MD |
| Country | United States |
| FEI number | 1118880 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: