Devices

Device Recall Guardian II NC Hemostasis Valve with Guidewire Introducer

Model / Serial
lots 27686, 27293, 22446
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, CT, DE, FL, GA, ID, IL IN , KY, LA,MD, MN, MO, NV, NM, NY, OH, PA, SC, TN, TX, VA, WA, and WV; and countries of: Italy and Korea. Italy, Korea
Product Description
Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. || Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
Manufacturer
Vascular Solutions, Inc.
1 Event
- Recall of Device Recall Guardian II NC Hemostasis Valve with Guidewire Introducer

Manufacturer

Vascular Solutions, Inc.

Manufacturer Address
Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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