Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.

FDA device recall Z-1040-2010 · posted 2010-03-09 · Terminated

Recall details

Recalling firm

Telefelx Medical

Reason for recall

When turned on, the Neptune heater may cause an artifact on the patient's heart monitor.

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.

Root cause

Device Design

Status

Terminated

Product code

BTT

Quantity affected

15,134 units

Distribution

U.S. Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland.

Date initiated

2010-01-12

Date posted

2010-03-09

Date terminated

2011-04-05

Location

Durham, NC

Related 510(k) clearances