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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Teleflex Medical
Reason for Recall:
The packages may contain foreign material (black particles).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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 Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1109-2015

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