Baxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
Baxter Healthcare is recalling two VOLARA systems because contamination in test equipment may have affected flow rate accuracy. Affected devices were returned and confirmed to meet specifications.
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 classified as FDA Class II, but the source text explicitly states that returned devices were tested and confirmed to meet specifications, indicating a low-risk or precautionary situation without reported injuries.
Plain-English summary
Baxter Healthcare Corporation is recalling two units of the VOLARA System (Model M08594A) in the United States. The recall was initiated because contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate.
The affected devices were distributed in Colorado and Florida. The specific serial numbers for the recalled units are W078SY3553 and Z309SY7853. The UDI for the product is 00887761981690.
According to the recall notice, the affected devices were returned to the firm. Testing confirmed that the devices meet specifications. Consumers should check their device serial numbers against the listed information and contact Baxter Healthcare for further instructions.
The recalled product
- Product
- Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Nebulizer
- Affected units
- 2
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 Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853
Distribution
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