Fresenius Medical Care Renal Therapies Group, LLC: Medical Device Recall in 2016 - (Recall #: Z-1325-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy

Product Classification:

Class II

Date Initiated: March 10, 2016

Date Posted: April 13, 2016

Recall Number: Z-1325-2016

Event ID: 73487

Reason for Recall:

Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)

Status: Terminated

Product Quantity: 8384 units (8369 US) (15 OUS)

Code Information:

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated