Stradis Healthcare Recalls Skin and Vein Packs Containing Recalled Gloves
Stradis Healthcare is recalling Skin and Vein Packs because they contain Devon Light Gloves that Medtronic is recalling.
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 measure triggered by the recall of a component (gloves) by the manufacturer, with no specific injuries or illnesses reported in the source text.
Plain-English summary
Stradis Healthcare, LLC. is recalling Skin and Vein Packs that contain Devon Light Gloves. These packs are used during surgery. The recall is being conducted because the manufacturer of the gloves, Medtronic, is recalling the Devon Light Glove component.
The affected product is identified by Pack 682-1218. The quantity involved is 3 units. 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 and healthcare facilities should stop using these specific packs and contact Stradis Healthcare for instructions on how to return or dispose of the product.
The recalled product
- Product
- Skin and Vein Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- 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 682-1218
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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