The Recall Desk

FDA (Devices) recall action 94696

Cook Incorporated recalled 2 products on 2024-07-03

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2024-07-03
Critical
0
Units
30

Why these products were recalled

Product labels state the incorrect expiration dates that extends beyond their true expiration date

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

1–2 of 2

  • HighFDA (Devices)··2024-07-03

    Drainage Catheter Recalled Due to Incorrect Expiration Dates on Labels

    Cook Incorporated is recalling 15 units of the Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter due to incorrect expiration dates on product labels that extend beyond the device's true expiration date. Affected units were distributed to Spain and the Netherlands.

    Product
    Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2024-07-03

    Cook Drainage Catheter Recall: Incorrect Expiration Date Labels

    Cook Incorporated is recalling 15 units of a multipurpose drainage catheter due to product labels stating incorrect expiration dates that extend beyond the devices' true expiration, creating a risk of expired device use.

    Product
    Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GP
    Category
    Distribution
    1 state