Recall Z-1332-2012 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Oridion Medical 1987 Ltd.
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; FilterL
| Date | Mar 29, 2012 (initiated Feb 16, 2012) |
| Status | Terminated |
| Reason | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. |
| Root cause | 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 | 2 million |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010024 | O2/CO2 NASAL FILTERLINE Oridion Medical 1987 , Ltd., Mar 14, 2001 |
| K011050 | MICROSTREAM ORAL NASAL CANNULA FILTERLINE Oridion Medical 1987 , Ltd., May 4, 2001 |
| K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE Oridion Medical 1987 , Ltd., Nov 14, 2001 |
| K980324 | MICROSTREAM FILLERLINE OR/EMS Oridion Medical , Ltd., Apr 16, 1998 |
| K980325 | MICROSTREAM NASAL CANNULA FILTERLINE Oridion Medical , Ltd., Apr 16, 1998 |
| K980327 | MICROSTREAM FILTERLINE ICU Oridion Medical , Ltd., Apr 16, 1998 |