Class 1 Device Recall Welch Allyn Life2000 Ventilation System

• Date Initiated by Firm: September 12, 2024
• Date Posted: October 22, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0046-2025
• Recall Event ID: 95398
• 510(K)Number: K170037
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• 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
• Code Information: UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBK