Reported Mar 27, 2013 · Terminated
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model…
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?
- Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass
- Model numbersFH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures
- Lot codes and dates
- Lot Number29835, and 30238.
1,524 of 1,524 codes
2913227295274032766027660280502824728247282472824728820291332983629836301263057930582276582824628246291322913229132276582765827658280412804128041280482804828245282452824528818288182881829131302383058027659280492913227294274023058231020562784274012765827658280412804128245288182913129131294532983530238
- Lot Number
- Amount recalled
- 79,869
Where it was sold
Why it was recalled
Stop using this product now
Risk that air may be introduced into the device which may lead to an air embolism.
Using this product could cause serious injury, illness or death — stop using it now.
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