Teleflex Medical: Medical Device Recall in 2015 - (Recall #: Z-1096-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

Product Classification:

Class II

Date Initiated: January 14, 2015

Date Posted: February 18, 2015

Recall Number: Z-1096-2015

Event ID: 70280

Reason for Recall:

The packages may contain foreign material (black particles).

Status: Terminated

Product Quantity: 15,779,607 units

Code Information:

Product Code: 001-40J, Lot numbers: 001139 & 003139.

Distribution Pattern:

Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.

Voluntary or Mandated:

Voluntary: Firm initiated