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U.S. Department of Health and Human Services

Class 2 Device Recall Oridion

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 Class 2 Device Recall Oridionsee related information
Date Initiated by FirmDecember 01, 2011
Date PostedMarch 30, 2012
Recall Status1 Terminated 3 on June 04, 2012
Recall NumberZ-1348-2012
Recall Event ID 61143
510(K)NumberK012395 
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
ProductOridion Surestream CO2 Sampling Lines- SureLine O2 Part Number: 010979-03 Product Usage: The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
Code Information Lot Numbers: M8204L10 M8357N10    
Recalling Firm/
Manufacturer		 Oridion Medical 1987 Ltd.
7 Hamarpe St., P.O. Box 45025
Har Hotzvim Industrial Park
Jerusalem Israel
Manufacturer Reason
for Recall		Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet
FDA Determined
Cause 2		Device Design
ActionOridion issued a Technical Note communication in March 2011 to field staff and end users globally. The Technical Note identified the affected product and provided instructions for user on the proper insertion of Surestream products. For questions contact your local distributor or Oridion at technicalsupport@oridion.com
Quantity in Commerce187 boxes (4675 units)
DistributionUSA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
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 = CCK
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