Stradis Healthcare Recalls Knee Arthro Packs Due to Component Recall
Stradis Healthcare is recalling Knee Arthro Packs because they contain a Devon Light Glove component that Medtronic is recalling.
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 of a medical device component. The source text does not report any illnesses, injuries, or deaths, and the hazard is theoretical pending the outcome of the component manufacturer's recall, fitting the criteria for a moderate severity score.
Plain-English summary
Stradis Healthcare, LLC. is recalling specific lots of Knee Arthro Pack and Knee Arthro Pack II. These convenience kits are used during surgery and contain a Devon Light Glove component. The recall is being conducted because the manufacturer of the component, Medtronic, is recalling the Devon Light Glove.
The affected products were distributed nationwide in the United States to specific states, as well as to Canada and Dubai. The specific pack codes involved in this recall are 888-2359, 888-2531, and 888-2351.
Healthcare facilities and consumers who have these specific packs should stop using them and contact Stradis Healthcare for further instructions regarding the recall.
The recalled product
- Product
- Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery
- Manufacturer
- Stradis Healthcare, LLC.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 3
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 (3)
- Pack 888-2359
- 888-2531
- 888-2351
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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