Z-0886-2025 Class I Ongoing
FDA device recall Z-0886-2025 was initiated by Baxter Healthcare Corporation on Dec 20, 2024 and is designated Class I. Reason for recall: There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 22, 2025
- Initiation Date
- Dec 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Reason for Recall
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Distribution Pattern
US, Nationwide Distribution
Code Information
UDI/DI 00887761981638, Serial Numbers: 122010001081