Stradis Face Neck Pack Recalled Due to Component Defect
Stradis Healthcare is recalling Face Neck Packs containing Devon Light Gloves due to a manufacturer recall of 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 without reported injuries or illnesses, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling Face Neck Packs that contain Devon Light Gloves. These products 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.
Healthcare facilities and consumers should stop using these Face Neck Packs and contact Stradis Healthcare for further instructions regarding the recall.
The recalled product
- Product
- Face Neck Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- 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 693-167
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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