Vascular Access Dressing Recalled Due to Lack of Sterility Assurance
DeRoyal Industries Inc. is recalling Covaderm Plus Vascular Access Dressings because they lack sterility assurance.
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 product is a Class II medical device recall involving a lack of sterility assurance, which is categorized as a low-risk contamination/precautionary issue.
Plain-English summary
DeRoyal Industries Inc. is recalling Covaderm Plus Vascular Access Dressings (Ref 46-406, 6"x6" / 15cmx15cm) due to a lack of sterility assurance.
This recall affects approximately 800 units distributed nationwide in the states of Florida and North Carolina. The affected product is identified by Lot number 63295141.
Consumers and healthcare providers should check their inventory for the affected lot and contact DeRoyal Industries Inc. for further information.
The recalled product
- Product
- DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 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 (1)
- Lot: 63295141/UDI: None
Distribution
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