The Recall Desk

FDA (Devices) recall action 70280

Teleflex Medical recalled 15 products on 2015-02-18

The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.

Products
15
Announced
2015-02-18
Critical
0
Units
236,694,105

Why these products were recalled

The packages may contain foreign material (black particles).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–15 of 15

  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because the packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak 340 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aqua 540 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aqua 540 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUA 540 SW, 540 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls 040 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling 040 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    ADAPTOR, 040 HUM, 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak Sterile Water Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak sterile water humidifier adaptors because packages may contain black particles.

    Product
    AQUAPAK SW/EAU STERILE, 650 ML W/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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak Sterile Water Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak sterile water humidifier adaptors because packages may contain black foreign particles.

    Product
    AQUAPAK SW/EAU STERILE, 340 ML W/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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls AQUAPAK 640 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling AQUAPAK 640 SW humidifier adaptors because packages may contain black particles. The recall covers 15,779,607 units distributed worldwide.

    Product
    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-02-18

    Teleflex Recalls Hudson RCI Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling specific Hudson RCI Humidifier Adaptors because the packages may contain black particles. The recall affects units distributed worldwide.

    Product
    Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340ML 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain foreign material, specifically black particles.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain black particles. The recall covers 15,779,607 units distributed worldwide.

    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 saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak 101 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak 101 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340 ML W/404 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI 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…
    Category
    Distribution
    0 states