Device recall

Z-0434-2013: SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign…

FDA device recall · Class II · Sentec AG

Key facts

Recall number (Z-number) Z-0434-2013
Recall event 63631
Product SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension…
Product code LKD
Recalling firm Sentec AG
Recall class Class II
Status Terminated
Termination date Dec 18, 2012
510(k) numbers K101690
FEI number 3004149774

At a glance

  • 1–9 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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