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U.S. Department of Health and Human Services

Class 2 Device Recall Microstream O2/CO2 NASAL FILTERLINE ADULT

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  Class 2 Device Recall Microstream O2/CO2 NASAL FILTERLINE ADULT see related information
Date Initiated by Firm May 26, 2010
Date Posted July 13, 2010
Recall Status1 Terminated 3 on June 21, 2012
Recall Number Z-1999-2010
Recall Event ID 55790
510(K)Number K010024  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product Microstream O2/CO2 NASAL FILTERLINE ADULT 25UN
Part Number: 006912
Code Information Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009,
Recalling Firm/
Manufacturer		 Oridion Medical 1987 Ltd.
7 Hamarpe St., P.O. Box 45025
Har Hotzvim Industrial Park
Jerusalem Israel
For Additional Information Contact
888-6743466
Manufacturer Reason
for Recall		 The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment.
FDA Determined
Cause 2		 Process design
Action Oridion notified customers by letter on 5/26/10 and requested that they remove the FilterLines from the related production lots from the field and an immediate replacement with FilterLines from subsequent production lots. Questions are directed to the responsible person at the supplier named in the letter, or to Oridion Capnography at 888-674-3466.
Quantity in Commerce 2 units
Distribution AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, 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 = CCK and Original Applicant = ORIDION MEDICAL 1987 LTD.
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