Stradis Vasc Custom Kits Recalled Due to Component Recall
Stradis Healthcare is recalling Vasc Custom Kits because they contain Devon Light Gloves, which are being recalled by the manufacturer Medtronic.
What this means for you
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 measure triggered by a component recall without specific reported injuries or illnesses in the source text, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling Vasc Custom Kits. These kits are used during surgery and contain Devon Light Gloves. The recall is being conducted because the manufacturer of the gloves, Medtronic, is recalling the Devon Light Glove component.
The recall involves 3 units of the Vasc Custom Kit, identified by Pack 682-126. The products 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. The products were also distributed to Canada and Dubai.
Consumers should stop using the affected Vasc Custom Kits and contact Stradis Healthcare for instructions on how to return the product.
The recalled product
- Product
- Vasc Custom Kit - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 3
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 682-126
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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