FDA (Devices) recall action 89868
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Product was sterilized with a higher than specification EO concentration.
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.
The ACS IR Angio Pack from American Contract Systems, Inc. was sterilized using ethylene oxide at higher than specification concentration. No illnesses or injuries have been reported.
American Contract Systems recalls ACS Lap Chole Pack surgical kits due to sterilization with ethylene oxide concentration exceeding manufacturer specification.
American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.
American Contract Systems recalls ACS Cath Lab Packs distributed in IL, MO, NE, and TX because they were sterilized with higher than specification ethylene oxide concentrations.
American Contract Systems is recalling ACS Spine Pack and ACS Lumbar/Back Set Up Tray surgical instrument sets due to improper sterilization with excess ethylene oxide. The affected sets were distributed in Illinois, Missouri, Nebraska, and Texas.