Teleflex Medical: Medical Device Recall in 2015 - (Recall #: Z-1101-2015)

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 340 SW, 340, ML 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-1101-2015

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: 003-40J, Lot numbers: 149147, 017147, 165147, 337137, 400137, 240137, 492137, 015147, 163147, 151147, 118147, 613137, 130137, 398137, 180137, 244137, 406137, 169147, 212137, 427137, 627137, 152147, 019147, 570137, 329137, 166147, 168147, 164147, 401137, 141147, 160147, 142147, 487137, 490137, 115147, 162147, 170147, 171147, 624137, 619137, 486137, 326137, 437137, 335137, 184137, 409137, 422137, 140147, 332137, 143147, 412137, 105147, 566137, 419137, 241137, 403137, 528137, 616137, 111147, 109147, 417137, 181137, 185137, 161147 & 146147.

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