Device recall

Z-0078-2012: Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006…

FDA device recall · Class II · Medtronic Perfusion Systems

Key facts

Recall number (Z-number) Z-0078-2012
Recall event 59948
Product Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acrylic) with silicone diaphragm on proximal end. Product utilizes a stopcock on proximal and/or distal end. Distal end of…
Product code DXS
Recalling firm Medtronic Perfusion Systems
Recall class Class II
Status Terminated
Termination date Oct 11, 2012
510(k) numbers K852232
FEI number 1000116158

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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