The Recall Desk

FDA (Devices) recall action 83827

Carroll-Baccari, Inc. recalled 2 products on 2019-11-20

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
2019-11-20
Critical
0
Units
27,424

Why these products were recalled

Product has the potential to be contaminated with Burholderia cepacia.

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.

1–2 of 2

  • HighFDA (Devices)··2019-11-20

    Carroll-Baccari Recalls Pedia Prep Skin Preparation Due to Contamination Risk

    Carroll-Baccari, Inc. is recalling Pedia Prep skin preparation products due to potential contamination with Burholderia cepacia. The recall affects 2,445 units distributed in the US, Canada, Spain, England, and Australia.

    Product
    Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-11-20

    Carroll-Baccari Lemon Prep Skin Preparation Recalled for Potential Contamination

    Carroll-Baccari, Inc. is recalling Lemon Prep skin preparation products due to potential contamination with Burholderia cepacia. The recall affects 24,979 units distributed in the US, Canada, Spain, England, and Australia.

    Product
    Lemon Prep: MD0019T - 4 oz tubes MD0019--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recording electrodes (i.e. EKG, ECG, etc.)
    Category
    Distribution
    0 states