APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines.
This recall has been terminated (originally issued November 11, 2004).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- September 15, 2004
- Posted
- November 11, 2004
- Terminated
- June 19, 2007
- Recall Number
- Z-0192-05
- Quantity
- 2321 units
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
rotating knob of the rotary style APL valve can become separated from the assembly.
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 / Code Info
APL Valve part number MK00625
Root Cause
Other
Action Taken
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.
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