Stradis Advanced Vein Care Kits Recalled Due to Component Recall
Stradis Healthcare is recalling Advanced Vein Care kits because they contain a Devon Light Glove component recalled by 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 a precautionary action taken due to a component recall by the manufacturer, with no reported illnesses or injuries in the source text, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling two Advanced Vein Care convenience kits. These kits are used during surgery and contain a Devon Light Glove component.
The recall is being conducted because the manufacturer of the component, Medtronic, has recalled the Devon Light Glove. The source text does not specify the reason for the component recall or report any illnesses or injuries.
The affected kits were distributed nationwide in the United States to specific states, as well as to Canada and Dubai. The specific pack code for the recalled items is 682-956. Consumers and healthcare providers should stop using these kits and contact the recalling firm for instructions.
The recalled product
- Product
- Advanced Vein Care - 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 682-956
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.
See all 51 products in this recall →Related recalls
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