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U.S. Department of Health and Human Services

Class 2 Device Recall accessory to ABL800 Flex

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  Class 2 Device Recall accessory to ABL800 Flex see related information
Date Initiated by Firm June 22, 2007
Date Posted October 11, 2007
Recall Status1 Terminated 3 on April 25, 2012
Recall Number Z-0038-2008
Recall Event ID 38511
510(K)Number K041874  
Product Classification Pump Tube, Waste - Product Code CHL
Product Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.
Code Information Serial #905-671, 902-754
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact Vincent Sigmund
440-871-8900 Ext. 209
Manufacturer Reason
for Recall		 Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use.
FDA Determined
Cause 2		 Process design
Action By telephone call or service representative visit beginning July 18, 2007, Consumers/End Users are asked to locate the analyzers and yearly service kits concerned and replace all pump tubes with new ones.
Quantity in Commerce 289 pieces
Distribution Product was distributed throughout the United States 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 MEDICAL APS
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