Z-1140-2023Class I

Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of...

Name: Z-1140-2023 Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of...
Creator: Baxter Healthcare Corporation
Published: 2023-01-25
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2023-01-25 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals on 2023-01-25. FDA classified it as Class I and gives the reason as "There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1140-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-01-25
Posted: 2023-02-24
Recalling firm: Baxter Healthcare Corporation
Product: Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
Product code: CBK Ventilator, Continuous, Facility Use
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 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 in commerce: 135 units
Distribution: Nationwide
Product codes and lots: a) REF BT20007, UDI 00887761978089, Serial Numbers: L191001-005, L191001-003, L191001-004, L191001-002, L191001-001, L191212-022, L191212-023, L191212-021, L191212-024, L191212-025, L200114-011, L200114-004, L200114-008, L1911019-015, L1911019-021, L1911019-023; b) REF BT-20-0007, UDI 00887761978089, Serial Numbers: L1911019-016, L1911019-020, L1911019-022, L2002006-032, L2003004-117, L2003004-085, L2003004-091, L2003004-121, L2002040-026, L2002040-039, L2002040-041, L2002011-033, L2002040-005, L2003004-145, L2003004-130, L2003004-128, L2003004-125, L2003004-123, L2003004-077, L2002040-040, L2002040-042, L2003004-131, L2003004-137, L2003004-144, L2003004-127, L2003004-133, L2003004-129, L2003004-115, L2003004-083, L2003004-087, L2002040-043, L2003004-079, L2003004-073, L2003004-098, L2003004-150, L2003004-181, L2003015-181, L2003015-189, L2003015-188, L2003015-180, L2003015-201, L2003015-205, L2003015-197, L2003015-203, L2003015-185, L2003015-186, L2003015-196, L2003015-198, L2003015-179, L2003015-202, L2003015-204, L2003015-178, L2003015-206, L2003015-309, L2003015-311, L2003015-349, L2003015-276, L2003015-275, L2004002-027, L2004002-015, L2003015-399, L2003015-395, L2003015-393, L2003015-265, L2003015-389, L2003015-391, L2003015-396, L2003015-397, L2003015-398, L2004002-020, L2004002-003, L2003015-384, L2003015-392, L2003015-277, L2003015-273, L2004002-262, L2004002-256, L2004002-263, L2004002-241, L2004002-174, L2004002-246, L2004002-265, L2004002-197, L2004002-170, 120210001615, 120190000718, 120190000711, 120190001264, 120190000088, 120190001269, 120190000078, 120190000089, 120210000884, 120190001266, 120190000092, 120190000730, 120190000075, 120190000706, 120190000737, 120190001275, 120190000728, 120190000093, 120190000707, 120210001613, 120210001608, 120190000077, 120190000091, 120190000074, 120210001614, 120190000714, L2005055-250, 120190000081, L2006020-252, 120190000079, L2005055-873, 120190000090, 120190000076, 120190000722, L2005055-898

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1140-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1139-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-24
Z-1140-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-24
Z-1141-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-24
Z-1142-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-02-24

Product code CBK

K170037Class IIBreathe Technologies Life2000™ Ventilation SystemBreathe Technologies / cleared 2017-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)