Z-1140-2023 Class I Ongoing
FDA device recall Z-1140-2023 was initiated by Baxter Healthcare Corporation on January 25, 2023 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 135 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2023
- Initiation Date
- January 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 135 units
Product Description
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
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.
Distribution Pattern
Nationwide
Code Information
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