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.
This recall has been terminated (originally issued September 23, 2014).
- Recall Initiated
- June 23, 2014
- Posted
- September 23, 2014
- Terminated
- January 29, 2021
- Recall Number
- Z-2686-2014
- Quantity
- 72 cases
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Product was held at temperature above the labeled recommended storage temperature
Distribution
Distributed in Texas.
Lot / Code Info
Lot Number: 14BMLB012
Root Cause
Storage
Action Taken
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.