Device recall

Z-1157-2007: The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar…

FDA device recall · Class II · Datascope Corporation

Key facts

Recall number (Z-number) Z-1157-2007
Recall event 38005
Product The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH 5mm curved scissors. Datascope Cardiac Assist Sterile Manufactured for: Datascope Cardiac Assist 15 Law Drive…
Product code GEI
Recalling firm Datascope Corporation
Recall class Class II
Status Terminated
Termination date Mar 4, 2008
510(k) numbers K003587
FEI number 1000222374

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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