Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP
FDA Recall #Z-0886-2025 — Class I — December 20, 2024
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.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
1 unit
Distribution
US, Nationwide Distribution
Code Information
UDI/DI 00887761981638, Serial Numbers: 122010001081
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated