—#138829

Product

Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB

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: Lots begin with: 15AMLB, 15BMLB, 15CMLB.

Why it was recalled

Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.

Root cause (FDA determination)

Process control

Action the firm took

Fresenius Medical NA issued an Urgent Expanded Medical Device Recall letter on 7/16/15 to clinics and patients. The letter identified the affected product, explained the reason for the expansion, and instructed users to immediately examine their stock to determine whether there was any Naturalyte Liquid Bicarbonate Concentrate beginning with 15AMLB, 15BMLB, 15CMLB. Users are to discontinue use immediately if any product of these lots is found, . All units are to be placed in a secure, segregated area. If affected product was on the machine prior to patient treatment, a [Heat Disinfect] program should be performed. The attached Reply Form should be completed and returned. Contact your FMCNA Customer Service Team at 1-800-323-5188 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: Nationwide Distribution

Timeline

Recall initiated: 2015-07-16
Posted by FDA: 2015-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138829. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.