Teleflex Medical: Medical Device Recall in 2012 - (Recall #: Z-2036-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.

Product Classification:

Class II

Date Initiated: June 12, 2012

Date Posted: July 25, 2012

Recall Number: Z-2036-2012

Event ID: 62284

Reason for Recall:

Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment.

Status: Terminated

Product Quantity: 14,794 each

Code Information:

Catalog #425-00, 425-10 and 425-30.

Distribution Pattern:

Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.

Voluntary or Mandated:

Voluntary: Firm initiated