—#129774

Product

Fresenius Naturalyte Liquid Bicarbonate Concentrate Product 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: 14BMLB012

Why it was recalled

Product was held at temperature above the labeled recommended storage temperature

Root cause (FDA determination)

Storage

Action the firm took

Fresenius Medical North America contacted customers via telephone on 6/23/14 by Customer Service and follow-up with formal letter notification, Urgent Recall by certified mail with signature confirmation and faxback form Customers instructed to examine their inventory to determine whether they have any of the affected Naturalyte Liquid Bicarbonate. If customers have the affected product, they are instructed to contact FMC-RTG Customer Service to have the product replaced. A revised/clarification letter dated 7/10/14 issued to state only products from the identified lots that were delivered by RTG LLC to the specified facilities on May 5, 2014 are affected by this recall as products were exposed to temperatures higher than their recommended storage temperature during transportation on May 5, 2014. If you have any additional questions, please contact your FMCNA Customer Service Team at 1-800-323-5188.

Recalling firm

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

Distribution

Distribution pattern: Distributed in Texas.

Timeline

Recall initiated: 2014-06-23
Posted by FDA: 2014-09-23
Terminated: 2021-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129774. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.