Recall Z-2400-2012— Vascular Solutions, Inc.
Class II · Terminated
Class II FDA medical device recall by Vascular Solutions, Inc., initiated 2012-08-30, terminated 2012-12-04. It names 2 FDA 510(k) clearances: K101113, K092711. Product: 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: 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..
- Recalling firm
- Vascular Solutions, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-30
- Terminated
- 2012-12-04
- Firm location
- Maple Grove, MN, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.