Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709
This recall has been terminated (originally issued December 29, 2009).
- Company
- Teleflex Medical
- Recall Initiated
- November 25, 2009
- Posted
- December 29, 2009
- Terminated
- April 7, 2011
- Recall Number
- Z-0585-2010
- Quantity
- 51 eaches
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
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.
Distribution
FL, KY, MI, OH, PA, SD, TN, Australia and Canada.
Lot / Code Info
Catalog number: 5804, Lot numbers 906018 and 906003.
Root Cause
Vendor change control
Action Taken
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.