FDA Enforcement
Class II
Terminated
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.
Recall: Z-0297-2017
·
Reported November 2, 2016
Enforcement
- Recall Number
- Z-0297-2017
- Event ID
- 75376
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- AccessClosure, Inc., A Cardinal Health Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- November 2, 2016
- Initiation Date
- October 6, 2016
- Classification Date
- October 21, 2016
- Termination Date
- November 14, 2016
- Address
- 5452 Betsy Ross Dr, Santa Clara, CA, 95054-1101, United States
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
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.
Code Info
Product Model ACX101, Manufacturer UDI *+ M465ACX10106* Lot No: F1614503
Distribution
US distribution to FL and NJ
Quantity
6 in USA