Stradis Minor Pack Surgical Kits Recalled Due to Component Issue
Stradis Healthcare is recalling Minor Pack and Minor Pack II surgical kits because they contain a recalled Devon Light 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 classified as FDA Class II. The source text describes a precautionary recall triggered by a component recall without reporting specific injuries, illnesses, or deaths, which aligns with the criteria for a moderate severity score.
Plain-English summary
Stradis Healthcare, LLC. is recalling Minor Pack and Minor Pack II convenience kits. These kits are used during surgery and contain a Devon Light Glove component.
The recall is being conducted because the manufacturer of the Devon Light Glove, Medtronic, has recalled that specific component. The kits are affected because they include this recalled glove.
The products were distributed nationwide in the United States to specific states, as well as to Canada and Dubai. Consumers and healthcare facilities should stop using these kits and contact Stradis Healthcare for further instructions.
The recalled product
- Product
- Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 2
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 (2)
- Pack 888-2381
- 888-2541
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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