| Date Initiated by Firm | February 16, 2012 |
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| Date Posted | March 29, 2012 |
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| Recall Status1 |
Terminated 3 on September 13, 2013 |
| Recall Number | Z-1333-2012 |
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| Recall Event ID |
61329 |
| 510(K)Number | K012391 K012395 K013845 K042665 K980324 K980327 |
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| 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; |
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| 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. |
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FDA Determined
Cause 2 | Packaging process control |
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| 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. |
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| Quantity in Commerce | 2 million |
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| Distribution | Nationwide Distribution |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = CCK
510(K)s with Product Code = CCK
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