Recalls / —
—#193263
Product
In-Line ventilator adaptor
- FDA product code
- NHJ — Device, Positive Pressure Breathing, Intermittent
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K200988
- Affected lot / code info
- M07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present.
Why it was 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.
Root cause (FDA determination)
Device Design
Action the firm took
The recall notification was sent to consignees on 04/26/2022 via FedEx. The customer was instructed to sign acknowledgement form to confirm receipt and return to Hillrom using pre-paid envelope.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2022-04-26
- Posted by FDA
- 2022-05-30
- Terminated
- 2024-08-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #193263. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.