In-Line ventilator adaptor
Reported: June 8, 2022 Initiated: April 26, 2022 #Z-1139-2022
Product Description
In-Line ventilator adaptor
Reason for Recall
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 9 units
- Distribution
- US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
In-Line ventilator adaptor. Recalled by Baxter Healthcare Corporation. Units affected: 9 units.
Why was this product recalled? ▼
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2022. Severity: Critical. Recall number: Z-1139-2022.
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