Device recall

Z-0536-2008: Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF…

FDA device recall · Class II · Ambu Incorporated

Key facts

Recall number (Z-number) Z-0536-2008
Recall event 44734
Product Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000 501, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
Product code BYE
Recalling firm Ambu Incorporated
Recall class Class II
Status Terminated
Termination date Jun 16, 2008
FEI number 1121788

At a glance

  • None 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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