Z-0046-2025Class I

Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2)...

Name: Z-0046-2025 Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2)...
Creator: Baxter Healthcare Corporation
Published: 2024-09-12
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-09-12 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of 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)... on 2024-09-12. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0046-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-09-12
Posted: 2024-10-22
Recalling firm: Baxter Healthcare Corporation
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
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Design Change
Action: 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."
Quantity in commerce: 10,957 units
Distribution: US nationwide distribution.
Product codes and lots: UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0046-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0046-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-22

Product code CBK

K170037Class IIBreathe Technologies Life2000™ Ventilation SystemBreathe Technologies / cleared 2017-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)