Vascular Solutions, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2400-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 30, 2012

Date Posted: September 26, 2012

Recall Number: Z-2400-2012

Event ID: 63098

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.

Status: Terminated

Product Quantity: 3500 units

Code Information:

lots 27686, 27293, 22446

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

Voluntary or Mandated:

Voluntary: Firm initiated