Class 1 Device Recall Breathe Technologies, Inc., Life2000

• Date Initiated by Firm: January 25, 2023
• Date Posted: February 24, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1141-2023
• Recall Event ID: 91506
• 510(K)Number: K170037
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
• Code Information: a) REF BT200011, UDI 00887761978089, Serial Numbers: L190606-014, L191011-040, L200127-015, L200204-013; b) REF BT-20-0011, UDI 00887761978089, Serial Numbers: L200226-012, L200226-013, L200226-015
• 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: There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
• FDA Determined Cause: Under Investigation by firm
• Action: Baxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its healthcare providers, wholesalers, distributor/reseller, and durable medical equipment providers on 01/25/2023 by USPS First Class Mail. The notice explained the issue and the hazard and requested the following actions be taken by adressee: "Please follow the daily checks and preventive maintenance requirements below to ensure the best oxygen delivery with the Life2000 ventilation system when used with a third-party oxygen concentrator. 1- Daily Checks a) Check the CombO2 hose and Breathe Pillow Interface for kinks, dirt, moisture, or damage and contact Baxter Customer Service at 800-426-4224, option 3, if replacement parts are needed. Baxter recommends replacing the Breathe Pillow Interface every 90 days and the CombO2 hose every six months. b) Do not modify, alter, or extend tubing, connectors, or interface. Additionally, when using the Life2000 system with an oxygen concentrator, only use Baxter s approved 6-foot, 20-foot or 50-foot CombO2 hose. c) Address alarms as described in the Life2000 Quick Reference Guide (PL-20-0044-D) pages 17-19. d) Make sure the CombO2hose is correctly attached to the Life2000 compressor and the oxygen concentrator, as shown in Attachment A, Figure 1. Make sure all connections are tight. e) Ensure the setting on the oxygen concentrator remains at the prescribed liter flow while connected to the Life2000 system as shown in the Life2000 Extended Range Configuration Quick Start Guide (APR186301). If the liter flow drops when you connect to the Life2000 system, take the following steps: - Stop using the Life2000 system and go back to your traditional oxygen cannula and concentrator. - Call Baxter s Clinical Support team at 800-397-9071 for troubleshooting. f) Please notify your health care team of any concerns or seek medical attention if you are exhibiting signs of respiratory distress (increased breathing rate, wheezing, bluish color around the mouth, lips or fingernails,
• Quantity in Commerce: 8 units
• Distribution: Nationwide
• 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 and Original Applicant = Breathe Technologies