Device recall

Z-1474-2008: Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen…

FDA device recall · Class II · Medline Industries Inc

Key facts

Recall number (Z-number) Z-1474-2008
Recall event 47225
Product Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS021; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.
Product code CAW
Recalling firm Medline Industries Inc
Recall class Class II
Status Terminated
Termination date Jun 17, 2010
510(k) numbers K043520
FEI number 1417592

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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