Teleflex Medical: Medical Device Recall in 2015 - (Recall #: Z-1103-2015)

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 640 SW, 650ML 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-1103-2015

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: 006-40, Lot numbers: 033136, 030136, 028136, 026136, 042146, 061146, 125136, 061136, 038146, 139136, 024136, 101136, 135136, 173136, 198136, 067136, 192136, 177136, 059136, 022146, 067146, 119136, 034136, 045146, 152136, 157136, 042136, 053136, 051146, 100136, 145136, 045136, 137136, 047136, 182136, 176136, 154136, 172136, 131136, 138136, 191136, 021146, 190136, 098136, 050146, 156136, 185136, 043136, 096136, 189136, 150136, 044136, 155136, 181136, 184136, 043146, 196136, 144136, 136136, 183136, 072136, 188136, 197136, 049146, 099136, 073136, 151136, 041136, 071136, 064146, 065146, 064136, 063136, 066136, 060146, 058136, 065136, 186136, 025136, 097136, 124136, 046136, 044146 & 066146.

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