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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 Containersee related information
Date Initiated by FirmApril 16, 2009
Date PostedJuly 15, 2009
Recall Status1 Terminated 3 on May 09, 2012
Recall NumberZ-1554-2009
Recall Event ID 51986
510(K)NumberK002290 K041874 
Product Classification Container, empty, for collection & processing of blood & blood components - Product Code CHL
ProductWaste 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 ContactMatt 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
ActionRadiometer 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 Commerce905-590 (D512): 35,552 bottles; 905-802 (D513): 45,204 bottles
DistributionWorldwide Distribution to US 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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