Z-0192-05

APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed...

Name: Z-0192-05 APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed...
Creator: Draeger Medical, Inc.
Published: 2004-09-15
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2004-09-15 / Terminated

FDA source

Draeger Medical, Inc. began a recall of APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia... on 2004-09-15. The reason FDA records is "rotating knob of the rotary style APL valve can become separated from the assembly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0192-05
Status: Terminated
Initiated: 2004-09-15
Posted: 2004-11-11
Terminated: 2007-06-19
Recalling firm: Draeger, Inc.
Product: APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: rotating knob of the rotary style APL valve can become separated from the assembly.
FDA root cause: Other
Action: The recalling firm issued a letter to their accounts informing them of the problem. The letter also informed the accounts that they would be contacted when the replacement knob was available to schedule the correction.
Quantity in commerce: 2321 units
Distribution: The product was shipped to medical supply companies, medical facilities nationwide. The product was also shipped to a government accounts in AR, FL, ID, LA, MA, MD, ME, NC, NY, OH, TX, VA, and VT. The product was also shipped to Canada, Germany, Korea, China, Australia, Singapore, Switzerland, and England
Product codes and lots: APL Valve part number MK00625

Product code BSZ

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)