Stradis Vein and Vascular Pack Recalled Due to Component Issue
Stradis Healthcare is recalling Vein & Vascular Packs because they contain a Devon Light Glove component that is being recalled by its manufacturer, Medtronic.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes it as a precautionary action driven by a component recall without reporting specific injuries, illnesses, or structural defects, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling one Vein & Vascular Pack, identified by code Pack 682-670. These convenience kits are used during surgery and contain a Devon Light Glove.
The recall is being conducted because the manufacturer of the Devon Light Glove component, Medtronic, is recalling that specific item. The source text does not specify the exact nature of the defect or hazard associated with the glove.
The affected packs were distributed nationwide in the United States to specific states including Alabama, Alaska, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Mexico, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington. Distribution also included Canada and Dubai. Consumers and healthcare facilities should stop using these packs and contact Stradis Healthcare for instructions on return or replacement.
The recalled product
- Product
- Vein & Vascular Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Pack 682-670
Distribution
Part of a larger recall action
This product is one of 51 recalled by Stradis Healthcare, LLC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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