Device recall

Z-2444-2015: Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product…

FDA device recall · Class II · Covidien LLC

Key facts

Recall number (Z-number) Z-2444-2015
Recall event 71784
Product Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
Product code MPO
Recalling firm Covidien LLC
Recall class Class II
Status Terminated
Termination date May 31, 2017
510(k) numbers K964523
FEI number 1219930

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

Browse all FDA device recalls (products)