—#86890

Product

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

FDA product code: CCL — Analyzer, Gas, Oxygen, Gaseous-Phase
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: Catalog number: 5804, Lot numbers 906018 and 906003.

Why it was recalled

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 (FDA determination)

Vendor change control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: FL, KY, MI, OH, PA, SD, TN, Australia and Canada.

Timeline

Recall initiated: 2009-11-25
Posted by FDA: 2009-12-29
Terminated: 2011-04-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.