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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 Oridion see related information
Date Initiated by Firm December 01, 2011
Date Posted March 30, 2012
Recall Status1 Terminated 3 on June 04, 2012
Recall Number Z-1346-2012
Recall Event ID 61143
510(K)Number K012391  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product Oridion Surestream CO2 Sampling Lines-
SureLine Adult
Part Number: 010976-03

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:  M8190L10, M8203L10, M8353N10   
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
Action Oridion 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 Commerce 19 units (475 boxes)
Distribution USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX 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 = CCK and Original Applicant = ORIDION MEDICAL 1987 LTD.
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