FDA (Devices) recall action 84587
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Mavidon is recalling all products manufactured at their facility.
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.
Carroll-Baccari, Inc. is recalling Mavidon CardioPrep Single products because samples were found contaminated with Burkholderia cepacia.
Carroll-Baccari, Inc. is recalling LemonPrep Tubes and Single use cups because samples tested positive for Burkholderia cepacia during an FDA inspection.
Carroll-Baccari, Inc. is recalling Wave Prep Tubes and single-use cups found to be contaminated with Burkholderia cepacia during an FDA inspection.
Mavidon is recalling PediaPrep Tubes and Single use cups because samples were found contaminated with Burkholderia cepacia during an FDA inspection.