Reported Mar 18, 2015 · Terminated
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Arrow International Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
- Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8
- Fr 40 cc ModelIAB-05840-LWS
- Lot codes and dates
- Lot NumberKF1111796 Exp
- Date11/30/2013
- Amount recalled
- 166 units
Where it was sold
Why it was recalled
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
This product could cause temporary or reversible health problems — stop using it.
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