Ventilation Device Handset Plug May Disconnect from Nebulizer Adapter
Baxter's Volara System SPU circuit kits may have a faulty handset plug that disconnects from the nebulizer adapter, preventing proper ventilator gas flow.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall affecting a critical respiratory medical device. Although no adverse events have been reported in the source material, the potential for the handset plug to disconnect and disrupt ventilator gas flow on a device essential for patient breathing warrants the Class I designation and Severe severity rating per the rubric.
Plain-English summary
Baxter Healthcare Corporation has recalled approximately 58,220 units of the Volara System Single Patient Use (SPU) Circuit kits, which are intermittent positive pressure breathing devices used to deliver ventilation support.
The handset plug used with this device may disconnect from the nebulizer port on the blue ventilator adapter. This plug is required for proper operation and to ensure correct ventilator gas flow. If the plug disconnects, the device may not deliver ventilation as intended.
The affected lots include units with product codes M08473 and M08474 and were distributed nationwide and internationally to Canada, France, and Germany. Consumers should verify their lot numbers against the recall list provided by the FDA.
Patients or healthcare providers currently using this device should discontinue use and contact Baxter Healthcare Corporation for instructions on obtaining replacement units or alternative devices. Do not attempt to use a device with a disconnected handset plug.
The recalled product
- 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.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- connector-failure
- ventilation-interruption
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 (20)
- Product Codes: M08473/M08474
- Lot numbers: 2171WA
- 2237WA
- 2238WA
- 2241WA
- 2242WA
- 2243WA
- 2244WA
- 2249WA
- 2250WA
- 2251WA
- 2285WA
- 2286WA
- 2290WA
- 2297WA
- 2298WA
- 2299WA
- 2307WA
- 2308WA
- 2311WA
Distribution
Distributed nationwide across the United States.
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