FDA Medical Device Recalls (openFDA)
Teleflex Medical: Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709
- Recall number
- Z-0585-2010
- Recalling firm
- Teleflex Medical
- Product
- Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709
- Status
- Terminated
- Initiated
- 2009-11-25
- Posted
- 2009-12-29
- Terminated
- 2011-04-07
- Reason
- 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
- 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
- 51 eaches
- Distribution
- FL, KY, MI, OH, PA, SD, TN, Australia and Canada.
- Lot, serial or model codes
- Catalog number: 5804, Lot numbers 906018 and 906003.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCL
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28