AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN
- Company
- American Medical Systems
- Recall Initiated
- February 19, 2007
- Posted
- April 3, 2007
- Terminated
- June 27, 2007
- Recall Number
- Z-0703-2007
- Quantity
- 5 devices
- Firm Location
- W Minnetonka, MN
Reason for Recall
Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
Distribution
Nationwide
Lot / Code Info
Lot 475175
Root Cause
Other
Action Taken
The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.
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