Device recall

Z-0703-2007: AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American…

FDA device recall · Class II · American Medical Systems

Key facts

Recall number (Z-number) Z-0703-2007
Recall event 37615
Product AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN
Product code FAE
Recalling firm American Medical Systems
Recall class Class II
Status Terminated
Termination date Jun 27, 2007
510(k) numbers K953640
FEI number 1000116179

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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