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U.S. Department of Health and Human Services

Class 2 Device Recall APL Valve used on some Fabius GS, Fabius Tiro and Narkomed 6000 series Anesthesia Machines

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 Class 2 Device Recall APL Valve used on some Fabius GS, Fabius Tiro and Narkomed 6000 series Anesthesia Machinessee related information
Date Initiated by FirmSeptember 15, 2004
Date PostedNovember 11, 2004
Recall Status1 Terminated 3 on June 19, 2007
Recall NumberZ-0192-05
Recall Event ID 30284
510(K)NumberK033498 K041266 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
ProductAPL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines.
Code Information APL Valve part number MK00625
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information ContactMichael Kelhart
215-721-5400 Ext. 2349
Manufacturer Reason
for Recall		rotating knob of the rotary style APL valve can become separated from the assembly.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce2321 units
DistributionThe 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BSZ
510(K)s with Product Code = BSZ
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