Stradis Plastic Packs Recalled Due to Medtronic Component Recall
Stradis Healthcare is recalling Plastic Packs containing Devon Light Gloves because the manufacturer, Medtronic, recalled the glove component.
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 from the manufacturer (Medtronic). The source text does not report any illnesses, injuries, or specific hazards associated with the Stradis kits themselves, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling Plastic Packs and Plastic HNP Packs that contain Devon Light Gloves. These convenience kits are used during surgery. The recall is being conducted because the manufacturer of the Devon Light Glove component, Medtronic, has recalled the gloves.
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 Pack 693-210, 693-054, 693-219, 888-2479, and 888-2499. The source text does not specify the total number of units recalled or report any illnesses or injuries associated with the product. Consumers and healthcare facilities should stop using these kits and contact the recalling firm for further instructions.
The recalled product
- Product
- Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 5
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 (5)
- Pack 693-210
- 693-054
- 693-219
- 888-2479
- 888-2499
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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