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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Waste Container

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  Class 2 Device Recall Disposable Waste Container see related information
Date Initiated by Firm April 16, 2009
Date Posted July 15, 2009
Recall Status1 Terminated 3 on May 09, 2012
Recall Number Z-1554-2009
Recall Event ID 51986
510(K)Number K002290  K041874  
Product Classification Container, empty, for collection & processing of blood & blood components - Product Code CHL
Product Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513.

The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.
Code Information Part Number: 905-590; Article Number: D512; Lot Numbers: WR-01, WR-02, WR-03, WS-01, WS-02, WS-03, WU-01, WU-02 and WU-03.  Part Number 905-802; Article Number: D513; Lot Numbers: WR-01, WR-02, WR-03, WR-04, WS-01, WS-02, WS-03, WS-04, WU-01, WU-02, WU-03, WU-04, WU-05, WU-06 and WY-01.
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145
For Additional Information Contact Matt Ackermann
440-871-8900 Ext. 209
Manufacturer Reason
for Recall		 When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
FDA Determined
Cause 2		 Process design
Action Radiometer America Inc. issued a recall notification letter dated May 5, 2009 to all customers containing information on replacement of all potentially defective waste containers and instruction on how to handle any mounted waste containers. For further questions, contact Radiometer America Inc. at 1-800-736-0600.
Quantity in Commerce 905-590 (D512): 35,552 bottles; 905-802 (D513): 45,204 bottles
Distribution Worldwide Distribution to US 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 A/S
510(K)s with Product Code = CHL and Original Applicant = RADIOMETER MEDICAL APS
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