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U.S. Department of Health and Human Services

Class 2 Device Recall CC cartridges for IRMA TRUPOINT Blood Gas Analyzer

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  Class 2 Device Recall CC cartridges for IRMA TRUPOINT Blood Gas Analyzer see related information
Date Initiated by Firm September 16, 2015
Date Posted October 23, 2015
Recall Status1 Terminated 3 on March 21, 2016
Recall Number Z-0159-2016
Recall Event ID 72305
510(K)Number K945240  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903.
The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
Code Information ASBEZ ASCXE ASEMB ASHWQ ASJMY ASLGI ASMXR ASOQO ASRXC ASTQR ASWZI 
Recalling Firm/
Manufacturer		 LifeHealth, LLC
2656 Patton Rd
Roseville MN 55113-1136
For Additional Information Contact Scott Blomberg
651-638-1114
Manufacturer Reason
for Recall		 May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were sent a LifeHealth "Urgent Medical Device Recall" letter dated September 16, 2015. The letter described the problem and the product involved in the recall. The letter described the Risk to Health, Action to be taken and Other Information. Consignees were advised to discontinue use and destroy all stock on hand. Requested consignees to complete and return the Verification Form to LifeHealth. For additional information contact Nancy Ring at 1-855-762-8978 or 651-638-1000, Monday through Friday, 8:30 AM to 4:30 PM, Central Time or see our website at www.lifehealthmed.com.
Quantity in Commerce 4659 boxes of 25. (116475 cartridges)
Distribution US: Nationwide (AL, AR, CA, CO, FL, IL, IN, IA, KS, KY, MD, MA,MI, MN, MS, MO, NE, NJ, NY,NC, OH, OK, PA, TN, TX, VA) OUS: ALBANIA, BELGIUM, BOLIVIA, CANADA, CHILE, CHINA, DENMARK. DOMINICAN REPUBLIC, ECUADOR, EGYPT, ENGLAND, ESTONIA, PHILIPPINES, FRANCE, GERMANY, GREECE, ICELAND, INDONESIA, IRELAND, ITALY, JAMAICA, JAPAN, MOROCCO, NETHERLANDS, NORWAY, PERU, PORTUGAL, SOUTH AFRICA, SOUTH KOREA, SPAIN, TAIWAN, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VIETNAM.
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 = CHL and Original Applicant = DIAMETRICS MEDICAL, INC.
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