Reported Nov 2, 2016 · Terminated
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed…
AccessClosure, Inc., A Cardinal Health Company
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: AccessClosure, Inc., A Cardinal Health Company · 5452 Betsy Ross Dr · Santa Clara, CA · 95054-1101
Is this the product you have?
- The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.
- Lot codes and dates
Product Model ACX101Manufacturer UDI *+ M465ACX10106*
- Lot NoF1614503
- Amount recalled
- 6 in USA
Where it was sold
Why it was recalled
AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy. This is a deviation from the firm's standard catheterization technique.
This product could cause temporary or reversible health problems — stop using it.
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