Stradis Healthcare Recalls Abdominal Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling Abdominal Packs and Abdom Packs because they contain Devon Light Gloves, a component recalled 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 explicitly states no illnesses or injuries have been reported. The hazard is theoretical and stems from a component recall, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
Stradis Healthcare, LLC. is recalling Abdominal Packs and Abdom Packs. These convenience kits are used during surgery and contain Devon Light Gloves. The recall is being conducted because the manufacturer of the gloves, Medtronic, has recalled the Devon Light Glove component.
The affected products are identified by Pack codes 670-056 and 681-014. The source text does not specify the quantity of units recalled, the specific dates of distribution, or the number of patients affected. The distribution pattern indicates 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 or Medtronic for instructions on how to return or dispose of the affected products. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- 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 670-056
- 681-014
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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