Teleflex Medical: Medical Device Recall in 2015 - (Recall #: Z-1102-2015)

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:

AQUA 540 SW, 540 W/040 ADAPTOR. 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-1102-2015

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: 005-40, Lot numbers: 005135, 015135, 017135, 029135, 010135, 035135, 006145, 003135, 018135, 034135, 019135, 023135, 028135, 010145, 004145, 008135, 009145, 002145, 030135, 002135, 031135, 016135, 022135, 026135, 021135, 008145, 032135, 007135, 004135, 007145, 009135, 027135, 001145, 005145, 012135, 006135, 020135, 033135, 013135, 001135, 011135, 036135, 025135, 014135 & 003145.

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