Stradis DND Pack Recalled Due to Medtronic Component Recall
Stradis Healthcare is recalling DND Packs containing Devon Light Gloves because the glove manufacturer, Medtronic, is recalling the 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 classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or specific high-risk hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stradis Healthcare, LLC. is recalling DND Packs, which are convenience kits used during surgery. These kits contain Devon Light Gloves. The recall is being conducted because the manufacturer of the gloves, Medtronic, is recalling the Devon Light Glove component.
The affected product is the DND Pack, specifically Pack 888-2595. The distribution pattern indicates the products were distributed nationwide in the United States to specific states, as well as to Canada and Dubai.
The source text does not specify the exact nature of the defect in the Devon Light Glove or report any specific injuries or illnesses associated with the use of these kits. Consumers and healthcare facilities should stop using the affected DND Packs and follow instructions from the recalling firm or the manufacturer regarding the return or disposal of the product.
The recalled product
- Product
- DND Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- 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 888-2595
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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