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U.S. Department of Health and Human Services

Class 2 Device Recall Caire Generation 4 electronic liquid level gauge

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  Class 2 Device Recall Caire Generation 4 electronic liquid level gauge see related information
Date Initiated by Firm October 23, 2007
Date Posted August 26, 2008
Recall Status1 Terminated 3 on December 17, 2009
Recall Number Z-1716-2008
Recall Event ID 47468
510(K)Number K050153  
Product Classification Electronic liquid level guage - Product Code BYJ
Product Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.
Code Information Liberator Base units - CBB300634XXXX - CBB300738XXXX. Includes units produced from week 34-2006 through week 38-2007.
Recalling Firm/
Manufacturer		 Caire, Inc.
1800 Sandy Plains Pkwy Ste 316
Marietta GA 30066-6363
For Additional Information Contact Ali Choudary
770-257-1276
Manufacturer Reason
for Recall		 Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.
FDA Determined
Cause 2		 Device Design
Action A Technical Service Bulletin was sent to consignees on/about October 23, 2007 to notify customers of the potential issue. Technical support and information for ordering replacement Generation 4 liquid gauges were offered. For technical concerns or if you have not received the notification from the firm, contact U.S. Technical Service at 1-800-482-2473 or European Technical Service at +44 (0) 797 1260077.
Quantity in Commerce 3470
Distribution U.S. Nationwide and the following foreign countries: Argentina, Austria, Brazil, Canada, China, Chile, Central America/Caribbean, Colombia, Costa Rica, Europe, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Irish Republic, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, Mexico, South America, Peru and Uruguay.
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 = BYJ and Original Applicant = CAIRE, INC.
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