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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 membranessee related information
Date Initiated by FirmJuly 05, 2013
Date PostedFebruary 24, 2014
Recall Status1 Terminated 3 on September 19, 2015
Recall NumberZ-1075-2014
Recall Event ID 67066
510(K)NumberK041874 K980130 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
ProductpCO2 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/
Manufacturer		 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
ActionOn 7/18/2013, the firm sent Product Notification letters to their customers.
Quantity in Commerce38,890 units (7,860 units imported into the US)
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = CHL
510(K)s with Product Code = CHL
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