FDA (Devices) recall action 85502
The FDA (Devices) publishes a recall like this one as 14 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 14 pages.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
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.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered with the FDA.
American Contract Systems is recalling sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.
American Contract Systems is recalling sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
American Contract Systems is recalling 2,868 surgical gown kits because they were manufactured in a facility not registered with the FDA.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.
American Contract Systems is recalling 2,868 sterile surgical kits because they were manufactured in a facility not registered with the FDA.
American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered by the FDA.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.