| Class 2 Device Recall Microstream SMART CAPNOLINE PLUS O2 |  |
Date Initiated by Firm | May 26, 2010 |
Date Posted | July 13, 2010 |
Recall Status1 |
Terminated 3 on June 21, 2012 |
Recall Number | Z-2013-2010 |
Recall Event ID |
55790 |
510(K)Number | K011536 |
Product Classification |
Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code cck
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Product | Microstream SMART CAPNOLINE PLUS O2 LONG 100 UN
Part Number: 010341
010341
Part Number: 10341 |
Code Information |
Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009, |
Recalling Firm/ Manufacturer |
Oridion Medical 1987 Ltd. 7 Hamarpe St., P.O. Box 45025 Har Hotzvim Industrial Park Jerusalem Israel
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For Additional Information Contact | 888-6743466 |
Manufacturer Reason for Recall | The Microstream Filterline may not be recognized by the monitor when connected. No CO2 readings will be displayed and no alarms may sound for unmonitored patients. Replacing the filterline may delay treatment. |
FDA Determined Cause 2 | Process design |
Action | Oridion notified customers by letter on 5/26/10 and requested that they remove the FilterLines from the related production lots from the field and an immediate replacement with FilterLines from subsequent production lots. Questions are directed to the responsible person at the supplier named in the letter, or to Oridion Capnography at 888-674-3466. |
Quantity in Commerce | 153,000 units (153 boxes/100 units) |
Distribution | AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI, |
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
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