Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2012 - (Recall #: Z-1826-2012)

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 NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. 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-1826-2012

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