Z-0297-2017 Class II Terminated
FDA device recall Z-0297-2017 was initiated by AccessClosure, Inc., A Cardinal Health Company on October 6, 2016 and is designated Class II. Reason for recall: 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 shea… The recall status is terminated (terminated November 14, 2016). Affected quantity: 6 in USA.
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2016
- Initiation Date
- October 6, 2016
- Termination Date
- November 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 in USA
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US distribution to FL and NJ
Code Information
Product Model ACX101, Manufacturer UDI *+ M465ACX10106* Lot No: F1614503