Baxter Healthcare Corporation Recall 90061
Description: In-Line ventilator adaptor
Baxter Healthcare Corporation Recall 90061 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1139-2022 |
| Event ID | 90061 |
| Event Description | In-Line ventilator adaptor |
| Product Type | Devices |
| 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. |
| Quantity | 9 units |
| Recall 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. |
| Device Classification | 20220608 |
| Device Code Info | M07937 MODULE, OPTIMUS HANDSET 2; UDI-DI: 00887761984622. Manufacturing dates October 17, 2019 to present. |
| Center Classification Date | 20220530 |
| Recall Initiation Date | 20220426 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
| Similar To |