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U.S. Department of Health and Human Services

Class 2 Device Recall Oxygen Sensor

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  Class 2 Device Recall Oxygen Sensor see related information
Date Initiated by Firm November 25, 2009
Date Posted December 29, 2009
Recall Status1 Terminated 3 on April 07, 2011
Recall Number Z-0585-2010
Recall Event ID 53937
510(K)Number K0000700  
Product Classification Analyzer, Gas, Oxygen, Gaseous-Phase - Product Code CCL
Product Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709
Code Information Catalog number: 5804, Lot numbers 906018 and 906003.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Michael Taggart
919-544-8000
Manufacturer Reason
for Recall		 Sensor causes the oxygen monitor to display prematurely a Low Sensor warning which indicates an early maintenance requirement for the instrument. This may result in interrupted treatment.
FDA Determined
Cause 2		 Vendor change control
Action Consignees were notified via next day delivery on or about 11/25/2009. Each customer received a letter requesting acknowledgement of the recall and a request to return the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second and third mailing to non-responding customers on the consignee list will be made, or as an alternative, the third contact may be by phone, e-mail, or fax. Affected products received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. Records of contacts and of destruction or rework will be maintained. Questions are directed to the company at 1-866-246-6990.
Quantity in Commerce 51 eaches
Distribution FL, KY, MI, OH, PA, SD, TN, Australia 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.
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