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 Recall Z-2686-2014 · Posted 2014-09-23
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Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKPO
Date Initiated2014-06-23
Date Terminated2021-01-29
Product Quantity72 cases
Reason for Recall
Product was held at temperature above the labeled recommended storage temperature
Firm Action
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.
Root Cause
Storage
Distribution Pattern
Distributed in Texas.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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