AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN
FDA Recall Z-0702-2007 · Posted 2007-04-03
Recalling FirmAmerican Medical Systems
Recall StatusTerminated
Product CodeFAE
Date Initiated2007-02-19
Date Terminated2007-06-27
Product Quantity5 devices
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.
Firm Action
The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.