American Medical Systems AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN
Brand
American Medical Systems
Lot Codes / Batch Numbers
Lot 475177
Products Sold
Lot 475177
American Medical Systems is recalling AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minn due to Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.
Recommended Action
Per FDA guidance
The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026