| 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-1332-2012 |
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| Recall Event ID |
61329 |
| 510(K)Number | K010024 K011050 K011536 K980324 K980325 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:
MicroStreamC02 Sampling Lines:
FilterLine Set Adult/Pediatric -Part No: XS04620-01;
FilterLine Set Adult/Pediatric (100 unit boxes)-Part No. 010579;
FilterLine H Set Adult/Pediatric -Part No. XS04624 ;
FilterLine H Set Adult/Pediatric (100 unit boxes) Part No: 010580;
FilterLine H Set Infant/Neonatal-Part No. 006324;
FilterLine Set Adult/Pediatric Long Part No. 007768;
FilterLine H Set Adult/Pediatric Long Part No. 007737;
FilterLine H Set Infant/Neonatal Long Part No. 007738
Smart CapnoLine Plus (O2 connector) Part No. 009818
Smart CapnoLine Plus (O2 connector) (Special 100 unit boxes) -
Part No.; 010209;
Smart CapnoLine Plus Long (O2 connector) Part No. 010340;
Smart CapnoLine Plus Long (O2 connector) (Special
100 unit boxes) Part No: 010339;
Smart CapnoLine Plus O2 (O2 tubing) Part No. 009822
Smart CapnoLine Plus O2 (O2 tubing) (Special 100 unit
boxes) Part No. 010210;
Smart CapnoLine Plus O2 Long (O2 tubing) Part No. 009826;
Smart CapnoLine Plus O2 Long (O2 tubing) (Special
100 unit boxes) , Part No. 010341;
Smart CapnoLine Pediatric Part No. 007266
Smart CapnoLine O2 Pediatric (O2 tubing) Part No. 07269;
Smart CapnoLine O2 Pediatric Long (O2 tubing) Part No.007743;
Smart CapnoLine H Plus O2 (O2 tubing) Part No. 010433;
Smart CapnoLine H O2 Adult (O2 tubing) Part No. 010478;
Smart CapnoLine H O2 Intermediate (O2 tubing) Part No; 010475;
Smart CapnoLine H Pediatric (O2 connector) Part No. 010581;
Smart CapnoLine H O2 Pediatric (O2 tubing) Part No. 010582
O2 CO2 Nasal FilterLine Adult (O2 connector) Part No. 010207;
O2 CO2 Nasal FilterLine Adult (O2 tubing) Part No. 006912;
O2 CO2 Nasal FilterLine Adult Long (O2 connector) Part No. 010342;
O2 CO2 Nasal FilterLine Adult Long (O2 tubing) Part No. 007739;
O2 CO2 Nasal FilterLine Pediatric (O2 tubing) Pat No. 006913;
O2 CO2 Nasal FilterLine Long (O2 tubing) Part No 007740;
NIV Line Adult Part No. 008174;
NIV Line Pediatric Part No. 008175;
Nasal FilterLine Infant/Neonatal Part No. XS0447;
CapnoLine H Adult Part No. 008177;
CapnoLine H Pediatric Part No. 008178;
CapnoLine H Infant/Neonatal Part No. 008179;
CapnoLine H O2 Adult (O2 tubing) Part No. 008180;
CapnoLine H O2 Pediatric (O2 tubing) Part No. 008181;
CapnoLine H O2 Infant/Neonatal (O2 tubing) Part No. 012111;
VitaLine H Set Adult/Pediatric Part No. 010787;
VitaLine H Set Infant/Neonatal Part No. 010807;
FilterLine XL Part No. 006325;
Smart CapnoLine Guardian Part No. 012528;
Smart CapnoLine Guardian O2 Part No. 012529;
Smart CapnoLine Guardian O2 Long Part No. 012530 |
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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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