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AccessClosure, Inc., A Cardinal Health Recalls
2 recalls on record · August 10, 2016 to November 2, 2016 · Medical Devices
November 2, 2016Medical DevicesFDA
AccessClosure, Inc., A Cardinal Health Company recalls The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed fo
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.
August 10, 2016Medical DevicesFDA
AccessClosure, Inc., A Cardinal Health Company recalls 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure De
Hazard: A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.