Aquapak 640 SW recall: Foreign Material

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product

AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile…

Recalling firm

Teleflex Medical

Quantity

15,779,607 units

Distribution

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.

Recall date

February 18, 2015

Classification

Class II

Status

Terminated

Agency

FDA (device)