FDA-Device2013-07-03Class II

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.

Terumo Medical Corporation
Hazard

Medical devices were incorrectly labeled with extended expiration dates.

Sold states
Nationwide Distribution.
Affected count
20 units
Manufactured in
950 Elkton Blvd, Elkton, MD, United States
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 human vasculature.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1611-2013

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