Recall Z-0376-2016— Windstone Medical Packaging, Inc.
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 4674 Custom Pack. For use in a general clinical procedure.. Reason: AMS 4674 Custom 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 4674 Custom Pack. For use in a general clinical procedure.
Reason for recall
AMS 4674 Custom 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.