Recall Z-1319-06 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
| Date | Aug 2, 2006 (initiated Jun 17, 2005) |
| Status | Terminated |
| Reason | The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range. |
| Root cause | Other |
| Action | The recalling firm notified their distributor/customers of this recall, via telephone on 6/17/2005, at which time, the customers were asked to destroy any and all suspect reference membranes found on-site and at their subaccount customer locations. |
| Quantity | 13 boxes/4 membranes per box |
| Distribution | Nationwide, including TX, OK, MI, CO, NY, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041874 | ABL800 FLEX Radiometer Medical Aps, Oct 8, 2004 |