FDA Device recall Z-0215-2022

Hemodialysis Delivery System, Software Version 2.x

FDA Device
Class II
ongoing
Published 2021-11-17

On 2021-11-17 the FDA classified a Class II recall of Hemodialysis Delivery System, Software Version 2.x by Baxter Healthcare, citing if the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the syst….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0215-2022
Classification	Class II
Status	ongoing
Initiated	2021-09-29
Published	2021-11-17
Last updated	2026-09-13 11:56 UTC
Company	Baxter Healthcare
Distribution	US

Product

Hemodialysis Delivery System, Software Version 2.x.

Reason

If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.

Identifiers

code_info	Software Version 2.x.; Product Code: 955626, UDI: 0085412639499 (Lot/Serial #107208, 107209, 107210, 107211, 107378… Software Version 2.x.; Product Code: 955626, UDI: 0085412639499 (Lot/Serial #107208, 107209, 107210, 107211, 107378, 107379, 107380, 107381, 107382, 107383, 107384, 107385, 107386, 107387, 107483, 107484, 107485, 107486, 107487, 107488, 107489, 107490, 107491, 107492, 107493, 107494, 107495, 107496, 107497, 107498, 107499, 107500, 107501, 107502, 107503, 107504, 107505, 107506, 107507, 107508, 107509, 107510, 107511, 107512, 107818, 107819, 107820, 107821, 107822, 107823, 107824, 107825, 107826, 107827, 107878, 107879, 107880, 107881, 107882, 107883, 107884, 107885, 107886, 107887, 108193, 108194, 108195, 108196, 108197, 108198, 108199, 108200, 108201, 108202, 108203, 108204, 108205, 108206, 108207, 108208, 108209, 108210, 108211, 108212, 108303, 108304, 108305, 108306, 108307, 108308, 108309, 108310, 108311, 108312, 108453, 108454, 108455, 108456, 108457, 108458, 108459, 108460, 108461, 108462, 108503, 108504, 108505, 108506, 108507, 108508, 108509, 108510, 108511, 108512, 108777,

code_info

Software Version 2.x.; Product Code: 955626, UDI: 0085412639499 (Lot/Serial #107208, 107209, 107210, 107211, 107378…

Software Version 2.x.; Product Code: 955626, UDI: 0085412639499 (Lot/Serial #107208, 107209, 107210, 107211, 107378, 107379, 107380, 107381, 107382, 107383, 107384, 107385, 107386, 107387, 107483, 107484, 107485, 107486, 107487, 107488, 107489, 107490, 107491, 107492, 107493, 107494, 107495, 107496, 107497, 107498, 107499, 107500, 107501, 107502, 107503, 107504, 107505, 107506, 107507, 107508, 107509, 107510, 107511, 107512, 107818, 107819, 107820, 107821, 107822, 107823, 107824, 107825, 107826, 107827, 107878, 107879, 107880, 107881, 107882, 107883, 107884, 107885, 107886, 107887, 108193, 108194, 108195, 108196, 108197, 108198, 108199, 108200, 108201, 108202, 108203, 108204, 108205, 108206, 108207, 108208, 108209, 108210, 108211, 108212, 108303, 108304, 108305, 108306, 108307, 108308, 108309, 108310, 108311, 108312, 108453, 108454, 108455, 108456, 108457, 108458, 108459, 108460, 108461, 108462, 108503, 108504, 108505, 108506, 108507, 108508, 108509, 108510, 108511, 108512, 108777,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0215-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.