Welch Allyn Life2000 (Baxter) – Pressure Alarm Failure (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00
Products Sold
UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-000 due to The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall sourc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
Recommended Action
Per FDA guidance
Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees 09/12/2024 via USPS first class mail. The notice explained the issue with the device, the hazard involved, and requested the following: "Actions to be Taken by Patients 1. Prior to starting therapy, patients should ensure that the Life2000 ventilator is connected to a pressure gas source (Life2000 compressor, oxygen cylinder, or wall source) first and then turned on. The system setup instructions can be found on the Quick Reference Guide, page 11-13. 2. Refer to Attachment A for the website link and QR code for the Quick Reference Guide, Instructions for Use and additional information regarding Troubleshooting Guidance. 3. If you received this communication directly from Baxter, acknowledge receipt of this letter using one of the two methods detailed on the enclosed Home Patient Reply Form Instruction Sheet. This step is required per FDA guidelines. Acknowledging receipt promptly will prevent you from receiving repeat notifications. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. Further Information and Support For general questions regarding this Urgent Medical Device Correction, please contact Advanced Respiratory, Inc. Home Care Customer Service at 800-426-4224, option 3, between the hours of 7:30 am and 6:00 pm Central Time or the Advanced Respiratory, Inc. Clinical Support team at 800-397-9071."
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