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 Eye Packs containing Devon Light Gloves due to a manufacturer recall of the glove component by Medtronic.
Stradis Healthcare is recalling Gyn Packs containing Devon Light Gloves because the manufacturer, Medtronic, recalled the glove component.
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 Abdominal Packs and Abdom Packs because they contain Devon Light Gloves, a component recalled by Medtronic.
Stradis Healthcare is recalling ACL Packs containing Devon Light Gloves because the manufacturer, Medtronic, is recalling the glove component.
Stradis Healthcare is recalling Bariatric Packs because they contain Devon Light Gloves that are subject to a separate manufacturer recall by Medtronic.
Stradis Healthcare is recalling surgical Set Up Packs because they contain Devon Light Gloves 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 Mississippi Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Stradis Healthcare is recalling Skin and Vein Packs because they contain Devon Light Gloves that Medtronic is recalling.
Stradis Healthcare is recalling surgical shoulder packs because they contain Devon Light Gloves that are subject to a separate manufacturer recall by Medtronic.
Stradis Healthcare is recalling surgical and general surgery packs because they contain Devon Light Gloves, a component being recalled by Medtronic.
Stradis Healthcare is recalling Stradi 4500 convenience kits because they contain a Devon Light Glove component that Medtronic is recalling.
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 Tummy Tuck Packs because they contain a Devon Light Glove component that is subject to a separate recall by Medtronic.
Stradis Healthcare is recalling Vaginal Rejuvenation Packs because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling Blepharoplasty Packs because they contain Devon Light Gloves, which are subject to a separate recall by Medtronic.
Stradis Healthcare is recalling surgical hand packs because they contain Devon Light Gloves, a component recalled by manufacturer Medtronic.
Stradis Healthcare is recalling Podiatry Packs because they contain Devon Light Gloves that are subject to a separate recall by Medtronic.
Stradis Healthcare is recalling Upper Extremity Packs because they contain a Devon Light Glove component being recalled 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 three Laser Evlt Packs and Laser One Leg Evlt kits because they contain a Devon Light Glove component recalled by Medtronic.
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 General Packs that contain Devon Light Gloves. The recall is necessary because the glove manufacturer, Medtronic, is recalling the specific glove component.
Stradis Healthcare is recalling Neurosurgery Packs because they contain Devon Light Gloves that are subject to a separate recall by Medtronic.