FDA Medical Device Recalls (openFDA)
Diametrics Medical, Inc.: IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A).
- Recall number
- Z-1072-03
- Recalling firm
- Diametrics Medical, Inc.
- Product
- IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A).
- Status
- Terminated
- Initiated
- 2003-07-14
- Posted
- 2003-07-30
- Terminated
- 2004-07-02
- Reason
- An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.
- Root cause
- Other
- Action
- The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.
- Quantity
- 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.
- Lot, serial or model codes
- The lot on the boxes of the product is ALHCB (this is the correct lot) and is incorrectly printed as ALOHC on the packages of the recalled disposable cartridges.
- 510(k) numbers
- K924758, K945240
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1000115726
- Firm city
- Roseville
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28