—#210132

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

FDA product code: CBK — Ventilator, Continuous, Facility Use
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K170037
Affected lot / code info: UDI/DI 00887761978089 or 00815410020537, All Life2000 Ventilators with software version 06.08.00.00

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.

Root cause (FDA determination)

Software Design Change

Action the firm took

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."

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US nationwide distribution.

Timeline

Recall initiated: 2024-09-12
Posted by FDA: 2024-10-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210132. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.