Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Oridion

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Oridion see related information
Date Initiated by Firm February 16, 2012
Date Posted March 29, 2012
Recall Status1 Terminated 3 on September 13, 2013
Recall Number Z-1333-2012
Recall Event ID 61329
510(K)Number K012391  K012395  K013845  K042665  K980324  K980327  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product Oridion CO2 sampling lines and water traps under the label:
Surestream CO2 Sampling Lines:
SureLine Adult Part No.010976;
sureLine Pediatric Part No. 010977;
SureLine O2 Adult Part No.010979;
SureLine O2 Pediatric Part No.010980
Smart SureLine Plus O2 Adult Part No. 010981;
Smart SureLine O2 Pediatric Part No. 010982;
Smart SureBloc O2 Part No. 010983;
Watertrap (package of 25 units) Part No. 010994;
Sure VentLine Set Adult/Pediatric Part No.010986;
Sure VentLine H Set Adult/Pediatric Part No.010987;
Smart SureLine Guardian O2 Part No.012533;
Smart SureLine Guardian O2 Long Part No.012534;
Code Information All lots
Recalling Firm/
Manufacturer		 Oridion Medical 1987 Ltd.
7 Hamarpe St., P.O. Box 45025
Har Hotzvim Industrial Park
Jerusalem Israel
Manufacturer Reason
for Recall		 CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
FDA Determined
Cause 2		 Packaging process control
Action Oridion notified Hospitals, Clinics, EMS with an "Important Communication" letter to clinicians dated February 12, 2012. The letter was intended to make US clinicians aware of an important issue relating to certain Oridion CO2 sampling lines, which may not fully meet quality requirements. In a few cases, paper and plastic particulate may be present in the packaged units at levels that exceed the visual specification. Recommended actions were included in the letter. Questions were directed to 1(781)-972-1252.
Quantity in Commerce 2 million
Distribution Nationwide Distribution
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.
510(K)s with Product Code = CCK and Original Applicant = ORIDION MEDICAL LTD.
-
-