Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2012 - (Recall #: Z-1827-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acute and chronic renal failure during hemodialysis procedure.

Product Classification:

Class I

Date Initiated: March 29, 2012

Date Posted: July 4, 2012

Recall Number: Z-1827-2012

Event ID: 62108

Reason for Recall:

Risk of Alkalosis with acetate containing dialysis acid concentrates

Status: Terminated

Product Quantity:

Code Information:

All lots

Distribution Pattern:

Nationwide Distribution and the country of Guam.

Voluntary or Mandated:

Voluntary: Firm initiated