Recall Z-0377-2016— Windstone Medical Packaging, Inc.

Name: FDA recall Z-0377-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-02

Class II · Terminated

Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2015-11-02, terminated 2016-08-17. FDA's recall record names no specific 510(k) clearance for this event. Product: AMS 4675 Angio Pack. For use in a general clinical procedure.. Reason: AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier..

Recalling firm: Windstone Medical Packaging, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-02
Terminated: 2016-08-17
Firm location: Billings, MT, United States

Product description

AMS 4675 Angio Pack. For use in a general clinical procedure.

Reason for recall

AMS 4675 Angio Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.