Stradis Healthcare Recalls Laser Evlt Packs Due to Component Recall
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.
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, but the source text explicitly states it is a precautionary recall due to a component recall by another manufacturer, with no reported illnesses or injuries, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling three units of Laser Evlt Pack and Laser One Leg Evlt kits. These convenience kits are used during surgery and contain a Devon Light Glove component.
The recall is being conducted because the manufacturer of the Devon Light Glove, Medtronic, has recalled that specific component. The source text does not specify the exact nature of the defect or hazard associated with the Devon Light Glove, nor does it report any illnesses or injuries.
The affected 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. The specific product codes involved are 682-670, 682-501, and 682-547.
The recalled product
- Product
- Laser Evlt Pack and Laser One Leg Evlt - 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 (3)
- Pack 682-670
- 682-501
- 682-547
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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