NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
- Recall Initiated
- May 20, 2015
- Posted
- June 22, 2015
- Recall Number
- Z-1827-2015
- Quantity
- 1,856,619 Bottles
- Firm Location
- Waltham, MA
Reason for Recall
Bacterial contamination.
Distribution
Nationwide Distribution
Lot / Code Info
Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.
Root Cause
Process control
Action Taken
Fresenius Medical Care sent an Urgent Medical Device Recall letter dated May 15, 2015, to all affected customers. Users were requested to Immediately examine stock to determine whether they have any Naturalyte Liquid Bicarbonate Concentrate of the lots. " If any product of these lots is found, discontinue use immediately. " Place all units in a secure, segregated area. " If affected product was on the machine prior to patient treatment, perform a [Heat Disinfect] program. " Your dialysis schedule should not be interrupted. If interruption of your dialysis schedule is expected, please discuss your options with your health care provider. " Contact FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product. " Promptly fill out and return the attached reply form Additional medical concerns or questions, please contact Medical Information and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com. For questions regarding this recall call 800-662-1237.