Z-2400-2012 Class II Terminated
FDA device recall Z-2400-2012 was initiated by Vascular Solutions, Inc. on August 30, 2012 and is designated Class II. Reason for recall: 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 pro… The recall status is terminated (terminated December 4, 2012). Affected quantity: 3500 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2012
- Initiation Date
- August 30, 2012
- Termination Date
- December 4, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3500 units
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.
Reason for Recall
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.
Distribution Pattern
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
Code Information
lots 27686, 27293, 22446