FDAFDA · Food and drugs·Recall number Z-2400-2012
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.
Published September 26, 2012 · Recall initiated: August 30, 2012
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
Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vascular Solutions, Inc.
- Distributor
- 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
- Lot
- lots 27686, 27293, 22446
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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