IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 di
FDA device recall Z-1072-03 · posted 2003-07-30 · Terminated
Recall details
- Recalling firm
- Diametrics Medical, Inc.
- Reason for recall
- An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.
- Action taken
- The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 103 boxes of 25 cartridges each.
- Distribution
- The product was shipped to 13 hospitals in California, Colorado, Florida, Iowa, Kansas, Minnesota, New Hamshire, Texas, and Wisconsin.
- Date initiated
- 2003-07-14
- Date posted
- 2003-07-30
- Date terminated
- 2004-07-02
- Location
- Roseville, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IRMA BLOOD ANALYSIS SYSTEM (K945240) | Diametrics Medical, Inc. | 1995-01-05 |
| DMI BLOOD GAS ANALYZER/CARTRIDGE (K924758) | Diamond Medical, Inc. | 1992-12-03 |