The Recall Desk

Manufacturer

Asante Solutions, Inc.

8 recalls in our database name Asante Solutions, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
4
Most recent
2014-01-08

Of the 8 recalls from Asante Solutions, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (50%) 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.

1–8 of 8

  • SevereFDA (Devices)·Z-0597-2014·2014-01-08

    Asante Comfort Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling 352 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0594-2014·2014-01-08

    Asante Comfort Infusion Set Recalled Due to Tubing Disconnects

    Asante Solutions is recalling 834 Comfort Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0598-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.

    Product
    Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0596-2014·2014-01-08

    Asante Comfort Infusion Set Recalled for Tubing Disconnection

    Asante Solutions is recalling 635 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnection and Insulin Leakage

    Asante Solutions is recalling Conset Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and delivering less insulin than intended.

    Product
    Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0595-2014·2014-01-08

    Asante Comfort Infusion Set Recalled for Tubing Disconnection and Insulin Leakage

    Asante Solutions is recalling 246 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery to patients.

    Product
    Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0600-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling 1,085 Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.

    Product
    Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide