Device recall

Z-2047-2009: Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan…

FDA device recall · Class I · Covidien Limited

Key facts

Recall number (Z-number) Z-2047-2009
Recall event 52927
Product Pedi-Cap CO2 Detector, 1 kg - 15 kg, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. Sold in packages of 6 (PediCap6) or 24 (PediCap). Intended for use during endotracheal or nasotracheal intubation to assist in verification of tube placement.
Product code CCK
Recalling firm Covidien Limited
Recall class Class I
Status Terminated
Termination date Jun 1, 2012
510(k) numbers K944400
FEI number 2936999

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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