Baxter Recalls PrisMax Hemodialysis Tubing Due to Performance Variability
Baxter Healthcare is recalling PrisMax System Version II hemodialysis tubing due to performance variability that may cause alarms and therapy interruptions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could lead to blood loss if therapy is interrupted, which fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Baxter Healthcare Corporation is recalling the PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System (ARPS) Pump Assembly tubing. The recall involves 2,314 units of tubing with model numbers 955626, 955558, and 955701, as well as the PrisMax V2 Preventive Maintenance Kit (Product Code SC616), ARPS Pump (Product Code SC6035), and ARPS Pump Assembly (Product Code SC6053). The products were distributed worldwide, including in the United States and numerous international countries.
The recall is due to variability in the performance of the tubing, which may lead to alarm situations during system self-tests and therapy. Specific alarm codes associated with this issue include B1215, B1273, B1116, B1539, B1541, and B1540. If an alarm occurs, it may lead to a delay or interruption of hemodialysis therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur. This tubing is normally replaced during annual preventative maintenance.
Healthcare facilities and users should check their inventory for the affected model numbers and serial numbers listed in the official recall notice. If the affected tubing is in use, it should be replaced according to the manufacturer's instructions to prevent potential therapy interruptions or blood loss.
The recalled product
- 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 As
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 2,314
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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