Z-0534-2008

Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer...

Name: Z-0534-2008 Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer...
Creator: Ambu Incorporated
Published: 2007-08-21
License: https://open.fda.gov/license/

Ambu Inc. / initiated 2007-08-21 / Terminated / root cause: manufacturing process

FDA source

Ambu Incorporated began a recall of Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu... on 2007-08-21. The reason FDA records is "Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0534-2008
Status: Terminated
Initiated: 2007-08-21
Posted: 2007-12-22
Terminated: 2008-06-16
Recalling firm: Ambu Inc.
Product: Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark
Product code: BYE Attachment, Breathing, Positive End Expiratory Pressure
Reason for recall: Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 197 total
Distribution: Nationwide.
Product codes and lots: Catalog Number: A000138000, Lot Number: 010017.

Product code BYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)