Stradis Healthcare Recalls Stradi 4500 Convenience Kits Due to Component Recall
Stradis Healthcare is recalling Stradi 4500 convenience kits because they contain a Devon Light Glove component that Medtronic is recalling.
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 classified as FDA Class II and is a precautionary measure triggered by a component recall from the manufacturer. No specific injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling Stradi 4500 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 issued a recall for the Devon Light Glove.
The affected product is identified by Pack 682-1102. The kits 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 product was also distributed to Canada and Dubai.
Consumers and healthcare facilities should stop using the affected Stradi 4500 convenience kits and contact Stradis Healthcare, LLC. for instructions on how to return the product.
The recalled product
- Product
- Stradi 4500 - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 1
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 682-1102
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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