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Life2000 recallZ-0046-2025 · Baxter Healthcare Corporation · initiated Sep 12, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software Design Change

What the company is doing

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."

Recall details

Recall number
Z-0046-2025
Status
Open, Classified
Initiated by the company
Sep 12, 2024
Posted by the FDA
Oct 22, 2024
Recalling firm
Baxter Healthcare Corporation
Quantity
10,957 units
Product code
CBK
FDA submissions
K170037
Distribution
US nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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