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U.S. Department of Health and Human Services

Class 2 Device Recall ABL700 FKEX and ABL800 FLEX pCO2 membranes

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  Class 2 Device Recall ABL700 FKEX and ABL800 FLEX pCO2 membranes see related information
Date Initiated by Firm July 05, 2013
Date Posted February 24, 2014
Recall Status1 Terminated 3 on September 19, 2015
Recall Number Z-1075-2014
Recall Event ID 67066
510(K)Number K980130  K041874  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH.

An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
Code Information Model #: 942-063 Lot #'s: R338 to R493
Recalling Firm/
Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1521
For Additional Information Contact
440-871-8900 Ext. 209
Manufacturer Reason
for Recall
RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results.
FDA Determined
Cause 2
Under Investigation by firm
Action On 7/18/2013, the firm sent Product Notification letters to their customers.
Quantity in Commerce 38,890 units (7,860 units imported into the US)
Distribution Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY, and the countries of Bermuda and Canada.
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 = RADIOMETER AMERICA, INC.
510(K)s with Product Code = CHL and Original Applicant = RADIOMETER MEDICAL APS