In-Line ventilator adaptor recall
In-Line ventilator adaptor
Why was In-Line ventilator adaptor 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
M07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present.
- Product
- In-Line ventilator adaptor
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 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.
- Recall date
- June 8, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)