The Recall Desk

FDA (Devices) recall action 79077

ICU Medical, Inc. recalled 6 products on 2018-04-18

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2018-04-18
Critical
0
Units
22,950

Why these products were recalled

The infusion sets were manufactured with an incorrect spin collar.

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.

States named across these recalls

1–6 of 6

  • ModerateFDA (Devices)··2018-04-18

    ICU Medical Recalls Infusion Sets with Incorrect Spin Collars

    ICU Medical is recalling 7,600 sterile intravascular administration sets because they were manufactured with an incorrect spin collar. The sets were distributed in the US, Canada, and Japan.

    Product
    14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile…
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2018-04-18

    ICU Medical Recalls 7-inch Intravascular Administration Sets with Incorrect Spin Collar

    ICU Medical is recalling 250 pouches of 7-inch intravascular administration sets because they were manufactured with an incorrect spin collar.

    Product
    7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for…
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2018-04-18

    ICU Medical Recalls Infusion Sets with Incorrect Spin Collars

    ICU Medical is recalling specific lots of sterile intravascular administration sets because they were manufactured with an incorrect spin collar.

    Product
    6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single…
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2018-04-18

    ICU Medical Recalls Smallbore Extension Sets with Incorrect Spin Collars

    ICU Medical is recalling 11,500 smallbore extension sets manufactured with incorrect spin collars. The affected units were distributed in the US, Canada, and Japan.

    Product
    6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use…
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2018-04-18

    ICU Medical Recalls 7-inch Smallbore Infusion Sets with Incorrect Spin Collar

    ICU Medical is recalling 2,950 sterile 7-inch smallbore infusion sets because they were manufactured with an incorrect spin collar. The affected lots were distributed in the US, Canada, and Japan.

    Product
    7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device…
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2018-04-18

    ICU Medical Recalls Smallbore Extension Sets Due to Incorrect Spin Collar

    ICU Medical is recalling 100 pouches of 5-inch Smallbore Extension Sets because they were manufactured with an incorrect spin collar.

    Product
    5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic…
    Category
    Distribution
    6 states