Events

Recall of Device Recall Ambu PEEP valve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ambu Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    44734
  • Event Risk Class
    Class 2
  • Event Number
    Z-0535-2008
  • Event Initiated Date
    2007-08-21
  • Event Date Posted
    2007-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66964
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    PEEP valve, ventilator accessory - Product Code BYE
  • Reason
    Lower pressure than expected: medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
  • Action
    Ambu notified consignees with a letter dated 08/21/07 and flagged as Trouble Shooting Guide. The letter advised that some valves do not hold the set PEEP level under certain conditions and consignees were further advised to consider the guideline as an addendum to existing directions for use. Consignees were instructed to return (to Ambu) for replacement the identified lots listed in the notification and confirm receipt of the advisory by e-m or fax. Ambu subsequently identified additional lots of valves and replacement valve parts for recall and notified all consignees by "Urgent Device Recall" letter dated 11/29/07. The letter advised healthcare practitioners of the impact on patient treatment that may result in less than effective treatment. Consignees were further advised to cease use of the device and return for replacement.

Device

Device Recall Ambu PEEP valve
  • Model / Serial
    Catalog Number: A137001000, Lot Numbers:  030046, and  040056.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
  • Manufacturer
    Ambu Incorporated

Manufacturer

Ambu Incorporated
  • Manufacturer Address
    Ambu Incorporated, 6740 Baymeadow Drive, Glen Burnie MD 21060-6412
  • Source
    USFDA