The Recall Desk

FDA (Devices) recall action 79789

Cook Inc. recalled 6 products on 2018-05-16

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
2018-05-16
Critical
0
Units
8,529

Why these products were recalled

Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.

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

  • HighFDA (Devices)··2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration

    Cook Inc. is recalling 6,345 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration

    Cook Inc. is recalling 886 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Fluid Leakage

    Cook Inc. is recalling 220 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiograp
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage

    Cook Inc. is recalling 304 connecting tubes because the cap-adapter assembly may not tighten adequately, potentially causing fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration

    Cook Inc. is recalling 554 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2018-05-16

    Cook Inc. Recalls Connecting Tubes Due to Potential Leakage

    Cook Inc. is recalling 220 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.

    Product
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic
    Category
    Distribution
    7 states