—#108033

Product

Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat. No. 13-2251-0. NaturaLyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

FDA product code: KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K981043
Affected lot / code info: Lot 11PTAC022. Expiration Date: 11/30/2013

Why it was recalled

Sodium content does not meet product requirements

Root cause (FDA determination)

Process control

Action the firm took

Fresenius Medical Care North America sent an "URGENT PRODUCT RECALL" letter dated March 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their stock immediately to determine whether they have any affected product. A fax back form was included for customers to complete and return. Contact FMCNA Customer Service Team at 1-800-323-5188 for questions regarding this notice.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2012-03-16
Posted by FDA: 2012-05-15
Terminated: 2014-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108033. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.