The Recall Desk

Manufacturer

ICU Medical de Mexico, S.A. de C.V.

20 recalls in our database name ICU Medical de Mexico, S.A. de C.V. as the manufacturing or recalling firm.

What the numbers show

Total
20
Critical
0
Severe
2
Most recent
2018-08-22

Of the 20 recalls from ICU Medical de Mexico, S.A. de C.V. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–20 of 20

  • SevereFDA (Devices)·Z-2811-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.

    Product
    61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2799-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2810-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold.

    Product
    38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2804-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2807-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2802-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall for I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2803-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and manifold.

    Product
    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2808-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of 150 pouches of smallbore I.V. administration sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2797-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2813-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2806-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2814-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets with NanoClave Manifold

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2816-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the luer and manifold.

    Product
    6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2809-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2812-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2798-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2801-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2815-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2805-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2800-2018·2018-08-22

    ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.

    Product
    DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids
    Category
    Medical Device
    Distribution
    7 states