Stradis Hand Pack Recall Due to Medtronic Glove Component Issue
Stradis Healthcare is recalling Hand Packs containing Devon Light Gloves due to a manufacturer recall of the glove component 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: This is a Class II recall involving a component recall by the manufacturer without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary action.
Plain-English summary
Stradis Healthcare, LLC. is recalling Hand Packs that contain Devon Light Gloves used during surgery. The recall is being conducted because the manufacturer of the glove component, Medtronic, is recalling the Devon Light Glove.
The affected products are identified by pack codes 888-2376, 888-2397, 888-2414, and 888-2471. The quantity involved is 4 units. These 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. Distribution also extended to Canada and Dubai.
Healthcare facilities and consumers should stop using these Hand Packs and contact Stradis Healthcare or Medtronic for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Hand Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Gloves
- Hazard
- Affected units
- 4
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 (4)
- Pack 888-2376
- 888-2397
- 888-2414
- 888-2471
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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