FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
- Recall number
- Z-1141-2023
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
- Status
- Open, Classified
- Initiated
- 2023-01-25
- Posted
- 2023-02-24
- Terminated
- not on file
- Reason
- There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
- Root 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
- 8 units
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K170037"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28