Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Diametrics Medical IRMA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Diametrics Medical IRMA see related information
Date Initiated by Firm July 14, 2003
Date Posted July 30, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall Number Z-1072-03
Recall Event ID 26714
510(K)Number K945240  K924758  
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
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).
Code Information 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.
Recalling Firm/
Manufacturer		 Diametrics Medical, Inc.
2658 Patton Road
Roseville MN 55113
For Additional Information Contact Nancy Ring
651-638-1250
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = DIAMETRICS MEDICAL, INC.
510(K)s with Product Code = JJE and Original Applicant = DIAMOND MEDICAL, INC.
-
-