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

FDA device recall Z-0585-2010 · posted 2009-12-29 · Terminated

Recall details

Recalling firm

Teleflex Medical

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.

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.

Root cause

Vendor change control

Status

Terminated

Product code

CCL

Quantity affected

51 eaches

Distribution

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

Date initiated

2009-11-25

Date posted

2009-12-29

Date terminated

2011-04-07

Location

Durham, NC