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U.S. Department of Health and Human Services

Class 2 Device Recall IRMA TRUPOINT

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  Class 2 Device Recall IRMA TRUPOINT see related information
Date Initiated by Firm April 29, 2015
Date Posted June 27, 2015
Recall Status1 Terminated 3 on October 20, 2015
Recall Number Z-1919-2015
Recall Event ID 71292
510(K)Number K945240  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.

Code Information 44803, 44805, 44807, 44808, 44818, 44830, 44837
Recalling Firm/
Manufacturer		 LifeHealth, LLC
2656 Patton Rd
Roseville MN 55113-1136
For Additional Information Contact Scott Blomberg
651-638-1123
Manufacturer Reason
for Recall		 The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were sent via e-mail a LifeHealth LLC " Urgent" letter dated April, 29th, 2015. The letter described the Purpose of this letter, Reason for the Voluntary Recall, Risk to Health, and Actions to be taken by the Customer. Advised consignees to immediately stop using the recalled product and return it to LifeHealth. Requested consignees to complete and return the Acknowledgement and Receipt Form.
Quantity in Commerce 7
Distribution Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.
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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