Device recall

Z-1459-2017: Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level…

FDA device recall · Class II · Terumo Cardiovascular Systems Corporation

Key facts

Recall number (Z-number) Z-1459-2017
Recall event 76458
Product Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.
Product code DTQ
Recalling firm Terumo Cardiovascular Systems Corporation
Recall class Class II
Status Terminated
Termination date Jun 1, 2017
510(k) numbers K153376
FEI number 1828100

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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