Recall Z-0192-05 ยท BSZ Gas-Machine, Anesthesia
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.
| Date | Nov 11, 2004 (initiated Sep 15, 2004) |
| Status | Terminated |
| 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 E |
| FDA record | Open on fda.gov |