FDA Recalls Covidien Devon Light Glove Sub-Assembly for Added Instructions
The FDA is recalling 118,800 units of the Covidien Devon Light Glove sub-assembly to add instructions for use regarding barrier integrity inspection.
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 an FDA Class II recall involving the addition of instructions for use to ensure barrier integrity inspection, which fits the criteria for moderate severity as it addresses a procedural safety measure without reported injuries.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 118,800 units of the Covidien Devon Light Glove sub-assembly, a non-sterile component used for kit packers. This product serves as a disposable, sterile, single-use cover for compatible surgical light handles. The recall is classified as Class II by the FDA.
The reason for the recall is to add Instructions for Use (IFU). Specifically, the updated instructions require users to inspect the Light Glove for barrier integrity after application. The affected products were distributed worldwide, including across the United States and various foreign countries such as Canada, the United Kingdom, and several European nations.
Healthcare facilities and consumers who possess these specific lot codes should stop using the product and follow the instructions provided by the recalling firm, Covidien LLC. The recall is limited to the addition of safety instructions and does not indicate a reported defect or injury in the source text.
The recalled product
- Product
- Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
- Manufacturer
- Covidien LLC
- Affected units
- 118,800
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)
- SURGI START 31145363 7496-88 STANDARD
- MINI-PLUS KIT 31145397 7497-8 STANDARD MINI PLUS KIT 31145413 7497-88 STANDARD
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Covidien 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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