FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines.
- Recall number
- Z-0192-05
- Recalling firm
- Draeger Medical, 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.
- Status
- Terminated
- Initiated
- 2004-09-15
- Posted
- 2004-11-11
- Terminated
- 2007-06-19
- Reason
- rotating knob of the rotary style APL valve can become separated from the assembly.
- 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
- 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
- Lot, serial or model codes
- APL Valve part number MK00625
- 510(k) numbers
- ["K033498","K041266"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28