Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
Reported: July 24, 2024 Initiated: May 30, 2024 #Z-2321-2024
Product Description
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 58,220 units
- Distribution
- Nationwide distribution. International distribution to Canada, France, and Germany.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.. Recalled by Baxter Healthcare Corporation. Units affected: 58,220 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Critical. Recall number: Z-2321-2024.
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