FDA (Devices) recall action 87722
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
The agency’s own wording, quoted from the enforcement report.
Medical Action Industries is recalling 180 Injection REVIEW MAI Kits because a component may have a package integrity breach.
Medical Action Industries is recalling 129 cases of Blood Culture MAI Kits because a component may have a package integrity breach.
Medical Action Industries is recalling LVAD Dressing Change Kits because a component may have a package integrity breach.
Medical Action Industries is recalling Central Line Dressing Change Kits due to a potential breach in the package integrity of a component.
Medical Action Industries is recalling 205 cases of Blood Culture Kits because a component may have a package integrity breach.
Medical Action Industries is recalling 110 cases of Midline Insertion Kits because a component may have a package integrity breach.