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Recall Observatory FDA recall evidence

Device product

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.

Z-1826-2012

March 29, 2012

Class I

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 62108
Status
Terminated
Classification
Class I
Quantity
Unavailable
Official record key
device-enforcement:Z-1826-2012

Official wording

Reason: Risk of Alkalosis with acetate containing dialysis acid concentrates

Code information: All lots

Distribution pattern: Nationwide Distribution and the country of Guam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Risk of Alkalosis with acetate containing dialysis acid concentrates