Z-2338-2008

Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating...

Name: Z-2338-2008 Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating...
Creator: Draeger Medical, Inc.
Published: 2008-07-07
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2008-07-07 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation on 2008-07-07. The reason FDA records is "The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable". 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-2338-2008
Status: Terminated
Initiated: 2008-07-07
Posted: 2008-09-23
Terminated: 2010-03-08
Recalling firm: Draeger, Inc.
Product: Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The product is used in operating rooms and ER, for patient intubation.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm has issued a MEDICAL DEVICE RECALL letter dated 7/7/08 to its customers via certified mail. The letter informs them of the problem and to exercise care when using the device until it has been retrofitted. Contact Drager Medical at 1-800-543-5047, #4 for assistance.
Quantity in commerce: 111 units
Distribution: Nationwide
Product codes and lots: Serial numbers: ARYA-xxxx, ARYB-xxxx, ARYC-xxxx, ARYD-xxxx, ARYE-xxxx, ARYF-xxxx, ARYH-xxxx, ARYJ-xxxx, ARYK-xxxx, ARYL-xxxx, ARYM-xxxx,ARYN-xxxx, ARZA-xxxx ARZB-xxxx (where xxxx represents any 4 digit number)

Product code BSZ

K042419Class IIFabius Gs/fabius Tiro Anesthesia SystemDraeger Medical, Inc. / cleared 2004-10-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)