PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: July 4, 2012 Initiated: March 29, 2012 #Z-1826-2012

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.

Reason for Recall

Risk of Alkalosis with acetate containing dialysis acid concentrates

Details

Distribution
Nationwide Distribution and the country of Guam.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Fresenius Medical Care Holdings, Inc..
Why was this product recalled? ▼
Risk of Alkalosis with acetate containing dialysis acid concentrates
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2012. Severity: Critical. Recall number: Z-1826-2012.

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