Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling Lines: OmniLine O2 Adult Part No.007609; OmniLine O2 Pediatric Part No 007610; Smart OmniLine Plus O2 Adult Part No.010177; Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213; Smart OmniLine O2 Pediatric Part No. 007606; ;Smart OmniBloc O2 Part No. 010946 Smart OmniLine Plus part No. 010172 Smart OmniLine Plus (package of 100 units) Part No 010212; Smart OmniLine Guardian O2 Part No. 012531; Smart OmniLine Guardian O2 Long Part No. 012532 OmniVentLine Set Part No. 012495
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-1334-2012
- 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.