Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Summary
The FDA issued a Class I for Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure b by Baxter Healthcare Corporation. Reason: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper ope.
Details
Source
Device Recall
External ID
Z-2322-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
Product Description
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Lot/Code Info: Product Code: M07937; Lot numbers: 4210495, 4325617.
Quantity Affected: 350 units
Reason for Recall
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
Distribution
Nationwide distribution. International distribution to Canada, France, and Germany.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-30
Company
Deerfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 198 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2322-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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