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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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.
  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. 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: 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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1103-2015

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