FDA Device recall Z-0713-2014
pO2 D999 membrane units
- FDA Device
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of pO2 D999 membrane units by Radiometer America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0713-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-10 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Radiometer America |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Part #: 942-042, Lot #: R0971 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0713-2014%22
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