Reported Mar 10, 2021 · Terminated
The PrisMax System Version II Hemodialysis Delivery System
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
The PrisMax System Version II Hemodialysis Delivery System
3 of 3 products
| Model / number | Product as published |
|---|---|
| — | 955626 |
| — | 955558 |
SC6053 | 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly |
- Lot codes and dates
- Model Numbersserial number, UDI
- a) 955626
1,206 of 1,206 codes
101227(01) 00085412639499 (21) 101227101280(01) 00085412639499 (21) 101280101292(01) 00085412639499 (21) 101292101293(01) 00085412639499 (21) 101293101327(01) 00085412639499 (21) 101327101348(01) 00085412639499 (21) 101348101352(01) 00085412639499 (21) 101352101353(01) 00085412639499 (21) 101353101389(01) 00085412639499 (21) 101389101391(01) 00085412639499 (21) 101391101393(01) 00085412639499 (21) 101393101394(01) 00085412639499 (21) 101394101398(01) 00085412639499 (21) 101398101422(01) 00085412639499 (21) 101422101423(01) 00085412639499 (21) 101423101450(01) 00085412639499 (21) 101450101452(01) 00085412639499 (21) 101452101456(01) 00085412639499 (21) 101456101791(01) 00085412639499 (21) 101791102142(01) 00085412639499 (21) 102142102151(01) 00085412639499 (21) 102151102152(01) 00085412639499 (21) 102152102153(01) 00085412639499 (21) 102153102154(01) 00085412639499 (21) 102154102155(01) 00085412639499 (21) 102155102159(01) 00085412639499 (21) 102159102312(01) 00085412639499 (21) 102312102318(01) 00085412639499 (21) 102318102326(01) 00085412639499 (21) 102326102328(01) 00085412639499 (21) 102328
- b) 955558
344 of 344 codes
100266(01) 07332414124359 (21) 100266100267(01) 07332414124359 (21) 100267100269(01) 07332414124359 (21) 100269100271(01) 07332414124359 (21) 100271100272(01) 07332414124359 (21) 100272100273(01) 07332414124359 (21) 100273100274(01) 07332414124359 (21) 100274100275(01) 07332414124359 (21) 100275100279(01) 07332414124359 (21) 100279100300(01) 07332414124359 (21) 100300100301(01) 07332414124359 (21) 100301100303(01) 07332414124359 (21) 100303100304(01) 07332414124359 (21) 100304100316(01) 07332414124359 (21) 100316100317(01) 07332414124359 (21) 100317100318(01) 07332414124359 (21) 100318100320(01) 07332414124359 (21) 100320100331(01) 07332414124359 (21) 100331100332(01) 07332414124359 (21) 100332100333(01) 07332414124359 (21) 100333100335(01) 07332414124359 (21) 100335100336(01) 07332414124359 (21) 100336100337(01) 07332414124359 (21) 100337100340(01) 07332414124359 (21) 100340100351(01) 07332414124359 (21) 100351100352(01) 07332414124359 (21) 100352100353(01) 07332414124359 (21) 100353100371(01) 07332414124359 (21) 100371100373(01) 07332414124359 (21) 100373100375(01) 07332414124359 (21) 100375
- Amount recalled
- 2314 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Baxter Healthcare Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.