The Recall Desk

FDA (Devices) recall action 94136

MEDLINE INDUSTRIES, LP - Northfield recalled 29 products on 2024-04-10

The FDA (Devices) publishes a recall like this one as 29 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 29 pages.

Products
29
Announced
2024-04-10
Critical
0
Units
1,158,478

Why these products were recalled

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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.

26–29 of 29

  • HighFDA (Devices)··2024-04-10

    Medline Centurion surgical kits recalled due to weak seal

    Medline Industries is recalling Centurion manual surgical kits because they may have weak seals that could compromise product sterility. The defect may not be noticeable to users before the kits are used.

    Product
    Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Sterile blood collection tubes recalled for weak seal defect

    MEDLINE INDUSTRIES is recalling Centurion 10mL sterile blood collection tubes due to weak seals that may compromise sterility and allow contamination if they fail.

    Product
    Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Centurion PICC Line Securement Kit Recalled for Weak Seal

    MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.

    Product
    Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-04-10

    Suture Removal and Staple Remover Kits Recalled for Weak Seal

    Medline Industries is recalling suture removal trays and staple remover kits due to weak seals that may compromise product sterility. Approximately 23,290 units were distributed in the US, Panama, and Canada.

    Product
    Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUT
    Category
    Distribution
    0 states