Recall Z-1333-2012 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Oridion Medical 1987 Ltd.
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. 0109
| 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
| K012391 | MAC-LINE CO2 NASAL CANNULA SAMPLE LINE Oridion Medical 1987 , Ltd., Aug 15, 2001 |
| K012395 | MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE Oridion Medical 1987 , Ltd., Aug 15, 2001 |
| K013845 | MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE Oridion Medical 1987 , Ltd., Nov 29, 2001 |
| K042665 | SMART BITEBLOC Oridion Medical 1987 , Ltd., Nov 23, 2004 |
| K980324 | MICROSTREAM FILLERLINE OR/EMS Oridion Medical , Ltd., Apr 16, 1998 |
| K980327 | MICROSTREAM FILTERLINE ICU Oridion Medical , Ltd., Apr 16, 1998 |