Recall Z-2321-2024— Baxter Healthcare Corporation
Class I · Ongoing
Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-05-30. It names 2 FDA 510(k) clearances: K200988, K192143. Product: 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: 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..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-05-30
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.