| Class 2 Device Recall Caire Generation 4 electronic liquid level gauge |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = BYJ
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