Stradis Cysto Pack Recalled Due to Component Recall by Medtronic
Stradis Healthcare is recalling Cysto Packs because they contain Devon Light Gloves, which are being recalled by the manufacturer 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 and is a precautionary measure triggered by a component recall without specific reported injuries or illnesses in the source text.
Plain-English summary
Stradis Healthcare, LLC. is recalling Cysto Packs, which are convenience kits used during surgery. The recall is necessary because the kits contain Devon Light Gloves, a component that is being recalled by its manufacturer, Medtronic.
The affected product is identified by Pack 888-2492. The distribution pattern indicates the products were distributed nationwide in the United States to specific states, as well as to Canada and Dubai.
Consumers should stop using the affected Cysto Packs and contact Stradis Healthcare for further instructions regarding the recall.
The recalled product
- Product
- Cysto 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 888-2492
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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