The PrisMax System Version II Hemodialysis Delivery System: Automatic… — Class II medical device recall Z-1151-2021
Terminated recall by Baxter Healthcare Corporation, reported 2021-03-10, distributed nationwide. Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which
| Recall number | Z-1151-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2021-01-07 |
| Classified | 2021-02-26 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2024-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CN, DE, DK, ES, FI, FR, GB, HR, IL, IT, JO, JP, KE, KR, KW, LT, MA, MT, MX, MY, NL, NO, NZ, PL, SE |
| Quantity | 2,314 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00085412639499, 07332414124359, 07332414125844 |
| Lot numbers | 1275298, 1275299, 1275517, 1276586, 1277559, 1277743, 1277956, 1277964, 1277965, 1277966, 1278423, 1278424, 1278425, 1278671, 1278909, 1281024, 1286623, 1286868, 1286869, 1286870, 1286871, 1286902, 1286903, 1287266 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1151-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.