FDA (Devices) recall action 84733
The FDA (Devices) publishes a recall like this one as 39 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 39 pages.
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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.
Cardinal Health is recalling ROYALSILK gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling specific lots of AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling AAMI 3 Royalsilk Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling AAMI 3 nonreinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling AAMI 3 Non-Reinf Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling AAMI 3 fabric-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling specific surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling AAMI 3 Royalsilk surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling AAMI 3 Nonreinforced Surgical Gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling specific lots of AAMI 3 surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.