FDA (Devices) recall action 71130
The FDA (Devices) publishes a recall like this one as 51 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 51 pages.
Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.
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.
Stradis Healthcare is recalling Knee Arthro Packs because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling Pediatric Packs containing Devon Light Gloves due to a manufacturer recall of the glove component by Medtronic.
Stradis Healthcare is recalling Glaucoma Packs because they contain Devon Light Gloves that are subject to a separate recall by Medtronic.
Stradis Healthcare is recalling Orthopedic Split Drape Packs because they contain a Devon Light Glove component recalled by Medtronic.
Stradis Healthcare is recalling Lima Pack surgical kits because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling Mississippi Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Stradis Healthcare is recalling Minor Pack and Minor Pack II surgical kits because they contain a recalled Devon Light Glove component.
Stradis Healthcare is recalling 15 endovenous kits because they contain Devon Light Gloves, a component recalled by Medtronic.
Stradis Healthcare is recalling Skin and Vein Packs because they contain Devon Light Gloves that Medtronic is recalling.
Stradis Healthcare is recalling Vasc Custom Kits because they contain Devon Light Gloves, which are being recalled by the manufacturer Medtronic.
Stradis Healthcare is recalling DND Packs containing Devon Light Gloves because the glove manufacturer, Medtronic, is recalling the component.
Stradis Healthcare is recalling Head & Neck Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Stradis Healthcare is recalling Vaginal Rejuvenation Packs because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling Custom Packs containing Devon Light Gloves due to a manufacturer recall of the glove component by Medtronic.
Stradis Healthcare is recalling Lipo/Buttocks Packs because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling 55 vein surgery packs because they contain a Devon Light Glove component subject to a separate recall by Medtronic.
Stradis Healthcare is recalling Face Lift Packs because they contain a Devon Light Glove that is being recalled by its manufacturer, Medtronic.
Stradis Healthcare is recalling Cysto Packs because they contain Devon Light Gloves, which are being recalled by the manufacturer Medtronic.
Stradis Healthcare is recalling Upper Extremity Packs because they contain a Devon Light Glove component being recalled by Medtronic.
Stradis Healthcare is recalling surgical convenience kits because they contain Devon Light Gloves that are subject to a separate recall by Medtronic.
Stradis Healthcare is recalling Advanced Vein Care kits because they contain a Devon Light Glove component recalled by Medtronic.
Stradis Healthcare is recalling Tummy Tuck Packs because they contain a Devon Light Glove component that is subject to a separate recall by Medtronic.
Stradis Healthcare is recalling Neurosurgery Packs because they contain Devon Light Gloves that are subject to a separate recall by Medtronic.
Stradis Healthcare is recalling Face Lift Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Stradis Healthcare is recalling Stradi 4500 convenience kits because they contain a Devon Light Glove component that Medtronic is recalling.