Z-1141-2023 Class I Ongoing
FDA device recall Z-1141-2023 was initiated by Baxter Healthcare Corporation on Jan 25, 2023 and is designated Class I. Reason for recall: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. The recall status is ongoing. Affected quantity: 8 units.
Recall details
- Product Type
- Devices
- Report Date
- Mar 8, 2023
- Initiation Date
- Jan 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product description
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
Reason for recall
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
Distribution pattern
Nationwide
Code information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1141-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026