FDA Device recall Z-1151-2021
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Number…
- FDA Device
- Class II
- terminated
- Published 2021-03-10
On 2021-03-10 the FDA classified a Class II recall of The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Number… by Baxter Healthcare, citing variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. Thi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1151-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-07 |
| Published | 2021-03-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053
Reason
Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it may lead to delay or interruption of therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur.
Identifiers
| code_info | Model Numbers: serial number, UDI; a) 955626: 101227, (01) 00085412639499 (21) 101227; 101280, (01) 00085412639499 (2…Model Numbers: serial number, UDI; a) 955626: 101227, (01) 00085412639499 (21) 101227; 101280, (01) 00085412639499 (21) 101280; 101292, (01) 00085412639499 (21) 101292; 101293, (01) 00085412639499 (21) 101293; 101327, (01) 00085412639499 (21) 101327; 101348, (01) 00085412639499 (21) 101348; 101352, (01) 00085412639499 (21) 101352; 101353, (01) 00085412639499 (21) 101353; 101389, (01) 00085412639499 (21) 101389; 101391, (01) 00085412639499 (21) 101391; 101393, (01) 00085412639499 (21) 101393; 101394, (01) 00085412639499 (21) 101394; 101398, (01) 00085412639499 (21) 101398; 101422, (01) 00085412639499 (21) 101422; 101423, (01) 00085412639499 (21) 101423; 101450, (01) 00085412639499 (21) 101450; 101452, (01) 00085412639499 (21) 101452; 101456, (01) 00085412639499 (21) 101456; 101791, (01) 00085412639499 (21) 101791; 102142, (01) 00085412639499 (21) 102142; 102151, (01) 00085412639499 (21) 102151; 102152, (01) 00085412639499 (21) 102152; 102153, (01) 00085412639499 ( |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1151-2021%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.