Reported Apr 13, 2016 · Terminated
Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101,…
Vascular Solutions, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vascular Solutions, Inc. · 6464 Sycamore Ct N · Maple Grove, MN · 55369-6032
Is this the product you have?
- Guardian II Hemostasis Valve, models 8210 and 8211. The following models
- are only available Outside the US
FH101FH101-TFH101-25and FH101-50
- Product UsageThe Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system
- The devices have two sealsthe low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi
- Lot codes and dates
- Lot numbers
4177641777418744210842525581766581767583285and 583286
- Lot numbers
- Amount recalled
- 5283
Where it was sold
Why it was recalled
Stop using this product now
Vascular Solutions became aware of a potential problem with the click version of the Guardian II hemostasis valves. The low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism.
Using this product could cause serious injury, illness or death — stop using it now.
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