FDA recall Z-3225-2026

Fresenius Medical Care Renal Therapies Group, LLC · Class II · device

Product

CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;

Reason for recall

Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

Distribution

Domestic: Nationwide Distribution;

Key facts

Status
Ongoing
Initiation date
2026-07-29
Report date
2026-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3225-2026