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Life2000 recallZ-1140-2023 · Baxter Healthcare Corporation · initiated Jan 25, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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,

Recall details

Recall number
Z-1140-2023
Status
Open, Classified
Initiated by the company
Jan 25, 2023
Posted by the FDA
Feb 24, 2023
Recalling firm
Baxter Healthcare Corporation
Quantity
135 units
Product code
CBK
FDA submissions
K170037
Distribution
Nationwide

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 91506).

Sources and updates

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