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U.S. Department of Health and Human Services

Class 2 Device Recall Oridion Capnostream20

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  Class 2 Device Recall Oridion Capnostream20 see related information
Date Initiated by Firm July 28, 2007
Date Posted November 28, 2007
Recall Status1 Terminated 3 on September 08, 2008
Recall Number Z-0177-2008
Recall Event ID 44926
510(K)Number K060065  
Product Classification Oximeter (Monitor) - Product Code DQA
Product Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical
Code Information Serial Numbers: B200001085 B200001254 B200001163 B200001153 B200001150 B200001135 B200001133 B200001086 B200001105 B200001104 B200001103 B200001102 B200001101 B200001325 B200001258 B200001272 B200001275 B200001289 B200001290 B200001291 B200001323 
Recalling Firm/
Manufacturer		 Oridion Capnography Inc
160 Gould St
Needham Heights MA 02494-2313
For Additional Information Contact
781-453-0500
Manufacturer Reason
for Recall		 Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.
FDA Determined
Cause 2		 Process design
Action Oridion sent Dear Customer letters dated, August 21, 2007, informing users that a new monitor with the improved handle will be shipped by August 31, 2007.
Quantity in Commerce 21
Distribution Nationwide Distribution- including states of AZ, CA, FL, MA, MO, OH, TX, WA, and WI,
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DQA and Original Applicant = ORIDION CAPNOGRAPHY, INC.
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