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;
This recall has been terminated (originally issued March 29, 2012).
- Company
- Oridion Medical
- Recall Initiated
- February 16, 2012
- Posted
- March 29, 2012
- Terminated
- September 13, 2013
- Recall Number
- Z-1333-2012
- Quantity
- 2 million
- Official Source
- View on FDA website ↗
Reason for Recall
CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
Distribution
Nationwide Distribution
Lot / Code Info
All lots
Root Cause
Packaging process control
Action Taken
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.