Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.
This recall has been terminated (originally issued March 9, 2010).
- Company
- Telefelx Medical
- Recall Initiated
- January 12, 2010
- Posted
- March 9, 2010
- Terminated
- April 5, 2011
- Recall Number
- Z-1040-2010
- Quantity
- 15,134 units
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
When turned on, the Neptune heater may cause an artifact on the patient's heart monitor.
Distribution
U.S. Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland.
Lot / Code Info
Product numbers: 425-00, 425-10 and 525-30, All lot and serial numbers.
Root Cause
Device Design
Action Taken
Teleflex consignees were notified via Urgent Medical Device Recall letter via next day delivery on/about 01/12/2010. They were asked to return all of 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 mailing to non-responders on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be reworked with software upgrade and placed back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. Records will be maintained accordingly.