The Recall Desk

FDA (Devices) recall action 86831

Merit Medical Systems, Inc. recalled 3 products on 2021-01-06

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
2021-01-06
Critical
0
Units
212

Why these products were recalled

Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.

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)··2021-01-06

    Merit Medical Systems Recalls Custom Embolization Kits Due to Sterility Concerns

    Merit Medical Systems is recalling 42 custom embolization kits because header bags may not be fully sealed, potentially compromising the sterile barrier and leading to infection.

    Product
    Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL)…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2021-01-06

    Merit Medical Systems Recalls Custom Angiography Kits with Sealing Defects

    Merit Medical Systems is recalling 90 custom angiography kits because header bags may not be fully sealed, potentially compromising the sterile barrier and leading to infection.

    Product
    Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2021-01-06

    Merit Medical Systems Recalls Cardiac Catheterization Kits Due to Sterility Concerns

    Merit Medical Systems is recalling 80 cardiac catheterization kits because header bags may not be fully sealed, potentially compromising sterility and increasing infection risk.

    Product
    Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel…
    Category
    Distribution
    3 states