D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
FDA device recall Z-1319-06 · posted 2006-08-02 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 13 boxes/4 membranes per box
- Distribution
- Nationwide, including TX, OK, MI, CO, NY, and Canada.
- Date initiated
- 2005-06-17
- Date posted
- 2006-08-02
- Date terminated
- 2011-09-14
- Location
- Westlake, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL800 FLEX (K041874) | Radiometer Medical Aps | 2004-10-08 |