Stradis Healthcare Recalls Glaucoma Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling Glaucoma Packs because they contain Devon Light Gloves that are subject to a separate recall 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 does not report any illnesses, injuries, or hospitalizations, and the hazard is a precautionary recall of a component rather than a direct high-risk pathogen or structural defect.
Plain-English summary
Stradis Healthcare, LLC. is recalling one unit of the Glaucoma Pack, Pack 687-395. This product is a convenience kit used during surgery that contains a Devon Light Glove.
The recall is being conducted because the manufacturer of the Devon Light Glove, Medtronic, is recalling that specific component. The Glaucoma Pack is being recalled due to the inclusion of this affected component.
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. Consumers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- Glaucoma Pack - 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 687-395
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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