Recall Z-0585-2010 ยท CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Teleflex Medical
Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709
| Date | Dec 29, 2009 (initiated Nov 25, 2009) |
| Status | Terminated |
| 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 |
| Quantity | 51 eaches |
| Distribution | FL, KY, MI, OH, PA, SD, TN, Australia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.