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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Baxter Healthcare Corporation
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1140-2023

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