The Recall Desk

FDA (Devices) recall action 85361

ICU Medical, Inc. recalled 7 products on 2020-05-20

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2020-05-20
Critical
0
Units
610

Why these products were recalled

Inability for the guidewire to pass through the needles included with the catheter kits.

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

1–7 of 7

  • ModerateFDA (Devices)··2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 20 Central Venous Catheters because the included guidewire cannot pass through the needles. The product was distributed to US consignees and Canada.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25.
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 60 units of Model 41406-23 Central Venous Catheters because the included guidewires cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 235 Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect

    ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles. The defect prevents proper use of the device.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 15 units of Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect

    ICU Medical is recalling 260 units of Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.
    Category
    Distribution
    19 states