Stradis Healthcare Recalls Surgical Set Up Packs Containing Recalled Devon Light Gloves
Stradis Healthcare is recalling surgical Set Up Packs because they contain Devon Light Gloves that Medtronic is recalling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a precautionary measure triggered by a component recall, with no specific injuries or illnesses reported in the source text.
Plain-English summary
Stradis Healthcare, LLC. is recalling Set Up Packs used during surgery. These convenience kits contain Devon Light Gloves, which are the subject of a separate recall by the manufacturer, Medtronic.
The affected product is identified by Pack 888-2546. The recall is limited to one unit. Distribution was nationwide in the United States to specific states, as well as Canada and Dubai.
Consumers and healthcare facilities should stop using the recalled Set Up Packs and contact Stradis Healthcare for further instructions.
The recalled product
- Product
- Set Up 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 888-2546
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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