Z-0713-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2014
- Initiation Date
- June 10, 2013
- Termination Date
- June 19, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 209 boxes/6 membranes
Product Description
pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
Reason for Recall
RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were produced with inner solution for pCO2 membrane units. This solution is a salt solution similar to the pO2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following Cal2 calibration.
Distribution Pattern
Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.
Code Information
Part #: 942-042, Lot #: R0971