Roscoe Mini Neb Compressor User Manual Recall for Warning Updates
Compass Health Brands is recalling 219,353 Roscoe Mini Neb Compressor user manuals to add warnings about proper handling and storage to reduce power cord damage.
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 classified as FDA Class II and involves a documentation update to prevent equipment damage (power cord wear), which aligns with the rubric for moderate severity involving minor labeling/documentation issues or low-risk contamination.
Plain-English summary
Compass Health Brands is recalling 219,353 user manuals for the Roscoe Mini Neb Compressor (models AG-MNEB and DS-NEB). The recall is necessary because the company identified the need to update the manuals with additional warning statements regarding the proper handling and storage of the nebulizer.
The updated warnings are intended to better inform end users of proper care when using and storing the device. The goal is to reduce user damage, specifically wear and tear, to the power cord. The affected manuals were distributed worldwide, including in the United States and various international countries.
Consumers with these manuals should check if they are affected by the recall. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.
- Manufacturer
- Compass Health Brands
- Category
- Medical Device — Nebulizer
- Affected units
- 219,353
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)
- Models AG-MNEB and DS-NEB
Distribution
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