Device recall

Z-1505-2013: FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.

FDA device recall · Class II · American Optisurgical Inc

Key facts

Recall number (Z-number) Z-1505-2013
Recall event 65098
Product FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Product code OJU
Recalling firm American Optisurgical Inc
Recall class Class II
Status Terminated
Termination date Mar 24, 2014
FEI number 1000135560

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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