Stradis Healthcare Recalls Bariatric Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling Bariatric Packs because they contain Devon Light Gloves that are subject to a separate manufacturer recall 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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. It is a precautionary recall driven by a component recall, fitting the criteria for a moderate severity score.
Plain-English summary
Stradis Healthcare, LLC. is recalling Bariatric Packs that contain Devon Light Gloves. These packs are used during surgery. The recall is being conducted because the manufacturer of the gloves, Medtronic, has recalled the Devon Light Glove component.
The affected product is identified by the code Pack 682-678. The distribution pattern indicates the product was distributed nationwide in the United States to specific states, as well as to Canada and Dubai. The source text does not specify the exact number of units recalled or the specific dates of distribution.
Consumers and healthcare facilities should stop using the affected Bariatric Packs and contact Stradis Healthcare for further instructions regarding the recall.
The recalled product
- Product
- Bariatric 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 682-678
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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