Recall Z-1139-2022 ยท NHJ Device, Positive Pressure Breathing, Intermittent
Baxter Healthcare Corporation
In-Line ventilator adaptor
| Date | May 30, 2022 (initiated Apr 26, 2022) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200988 | Maximus System Hill-Rom Services Pte, Ltd., May 26, 2020 |