Baxter Healthcare Corporation Recall 91506
Description: Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Baxter Healthcare Corporation Recall 91506 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1141-2023 |
| Event ID | 91506 |
| Event Description | Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 8 units |
| Recall Reason | There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. |
| Device Classification | 20230308 |
| Device Code Info | a) REF BT200011, UDI 00887761978089, Serial Numbers: L190606-014, L191011-040, L200127-015, L200204-013; b) REF BT-20-0011, UDI 00887761978089, Serial Numbers: L200226-012, L200226-013, L200226-015 |
| Center Classification Date | 20230224 |
| Recall Initiation Date | 20230125 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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