Salter Labs Recalls T-piece Nebulizers Due to Fit Issues
Salter Labs is recalling 70 T-piece Nebulizers because the T-piece does not fit on the nebulizer. The devices were distributed in six US states and China.
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. The hazard involves a functional defect (fit issue) without reported injuries or illnesses, aligning with the criteria for moderate severity involving low-risk issues or voluntary precautionary measures.
Plain-English summary
Salter Labs is recalling 70 units of T-piece Nebulizers with in-line connectors, Part number 8915-7-50. These are single-patient use, non-sterile prescription devices designed for use in hospital or home care environments.
The recall was initiated due to reports that the T-piece does not fit on the nebulizer. The affected units are from Lot No. 083115, 090715, and 122815.
The devices were distributed in the states of Texas, New York, Pennsylvania, Tennessee, South Carolina, and Ohio, as well as in China. Consumers and healthcare providers should stop using the affected devices and contact Salter Labs for instructions on return or replacement.
The recalled product
- Product
- T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.
- Manufacturer
- Salter Labs
- Hazard
- Affected units
- 70
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 (3)
- Lot No. 083115
- 090715
- and 122815
Distribution
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