Life2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081
Products Sold
UDI/DI 00887761978089 or 00815410020537, Serial Numbers: 122010001081
Baxter Healthcare Corporation is recalling Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/20/2024 via USPS first class mail. The notice explained the problem with the device, hazard involved, and requested the following actions be taken: 1. Always have an alternate means of ventilation or oxygen therapy available. 2. Patients may continue using the Life2000 ventilator if it is functioning correctly. If the ventilator becomes inoperable, place the patient on an alternate means of ventilation, if necessary, and contact Baxter Advanced Respiratory, Clinical Support team at 800-397-9071. 3. In the interim if patients experience this failure and have an additional charger available, connect it to the ventilator and verify that the ventilator is charging. 4. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any remaining inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. 6. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to the Director of Respiratory Therapy, Patient Safety, and any other departments within your institution who use the affected product. 7. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal. Durable Medical Equipment providers are required to notify patients of this Urgent Medical Device Correction by forwarding the attached home patient letter. For general questions regarding this Urgent Medical Device Correction, please contact the Baxter Advanced Respiratory team at 800
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026