The Recall Desk

FDA (Devices) recall action 94622

Integra LifeSciences Corp. recalled 3 products on 2024-06-19

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2024-06-19
Critical
0
Units
300

Why these products were recalled

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.

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

1–3 of 3

  • HighFDA (Devices)··2024-06-19

    EVD Catheter Sterile Packaging Defect Recall for Intracranial Drainage

    Integra LifeSciences is recalling CODMAN BACTISEAL EVD catheters due to external packaging seal defects that may compromise sterility. The recall affects 59 units distributed internationally.

    Product
    CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2024-06-19

    CODMAN BACTISEAL EVD Catheter Set: Sterile packaging defect recalled

    Integra LifeSciences is recalling 135 CODMAN BACTISEAL EVD Catheter Sets due to defects in sterile packaging that may compromise product sterility.

    Product
    CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial p
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2024-06-19

    CODMAN EVD BACTISEAL Catheter Sterile Packaging Defect Recall

    Integra LifeSciences recalls CODMAN EVD BACTISEAL catheters due to defects in sterile packaging that may compromise product sterility. The defect affects 106 units distributed worldwide.

    Product
    CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intra
    Category
    Distribution
    1 state