Teleflex Medical: Medical Device Recall in 2015 - (Recall #: Z-1109-2015)

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, INTL. 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-1109-2015

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: 400640, Lot numbers: 002146, 018136, 039136, 022136, 143136, 109136, 134136, 053146, 180136, 069146, 080136, 169136, 048146, 086136, 006146, 175136, 063146, 037146, 055146, 032146, 049136, 057136, 195136, 193136, 012146, 082136, 024146, 070136, 088136, 020136, 031146, 035146, 092136, 149136, 170136, 019136, 107136, 016146, 025146, 160136, 090136, 130136, 140136, 030146, 003146, 095136, 059146, 161136, 166136, 068146, 079136, 141136, 046146, 054136, 018146, 105136, 194136, 162136, 036146, 010146, 057146, 058146, 009146, 077136, 011146, 163136, 047146, 133136, 142136, 148136, 122136, 055136, 054146, 078136, 017146, 085136, 050136, 056136, 084136, 108136, 094136, 062146, 091136, 069136, 158136, 106136, 174136, 004146, 089136, 121136, 117136, 051136, 164136, 026146, 118136, 093136, 168136, 179136, 167136, 019146, 123136, 041146, 129136, 005146, 052136, 128136, 116136 & 021136.

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