FDAFDA · Food and drugs·Recall number Z-1611-2013
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.
Published July 3, 2013 · Recall initiated: May 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medical devices were incorrectly labeled with extended expiration dates.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Medical Corporation
- Distributor
- Nationwide Distribution.
- Lot
- Lot MM27
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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