| Class 2 Device Recall Oxygen Sensor | |
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 |
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 |
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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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