—#127081

Product

NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam 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: K071387
Affected lot / code info: Lot Number: 14CMLB006

Why it was recalled

Container cap may contain foreign material- 0.60% - 0.80% Manganese

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Fresenius Medical notified customer by letter dated 5/1/14 to examine stock immediately and instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to FMC-RTG. The customer instructed to contact the Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product.

Recalling firm

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

Distribution

Distribution pattern: Distributed in the state of MO.

Timeline

Recall initiated: 2014-05-01
Posted by FDA: 2014-06-09
Terminated: 2016-06-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127081. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.