The Recall Desk

FDA (Devices) recall action 93550

Natus Medical Incorporated recalled 2 products on 2024-01-10

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
2024-01-10
Critical
0
Units
6,022

Why these products were recalled

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

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)··2024-01-10

    External Drainage System Collection Bags Recalled for Sterility Assurance Issues

    Natus Medical Incorporated is recalling 2,686 units of External Drainage System Collection Bags due to incomplete bioburden testing that prevents sterility assurance. Healthcare facilities and patients should contact the manufacturer or their healthcare provider for guidance.

    Product
    External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
    Category
    Distribution
    41 states
  • HighFDA (Devices)··2024-01-10

    EDS 3 CSF External Drainage System recalled for incomplete sterility testing

    Natus Medical is recalling 3,336 units of the EDS 3 CSF External Drainage System nationwide because incomplete bioburden testing cannot guarantee sterility. No illnesses have been reported, but non-sterile devices pose infection risk.

    Product
    EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
    Category
    Distribution
    41 states