FDAFDA · Food and drugs·Recall number Z-0297-2017
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.
Published November 2, 2016 · Recall initiated: October 6, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- AccessClosure, Inc., A Cardinal Health Company
- Distributor
- US distribution to FL and NJ
- Lot
- Product Model ACX101, Manufacturer UDI *+ M465ACX10106* Lot No: F1614503
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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