Z-0585-2010

Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709

Name: Z-0585-2010 Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709
Creator: Teleflex Medical
Published: 2009-11-25
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2009-11-25 / Terminated / root cause: supplier

FDA source

Teleflex Medical began a recall of Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709 on 2009-11-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0585-2010
Status: Terminated
Initiated: 2009-11-25
Posted: 2009-12-29
Terminated: 2011-04-07
Recalling firm: Teleflex Medical
Product: Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709
Product code: CCL Analyzer, Gas, Oxygen, Gaseous-Phase
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.
Root cause tag: supplier
FDA root cause: 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.
Product codes and lots: Catalog number: 5804, Lot numbers 906018 and 906003.

Product code CCL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)