Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
- Recall Initiated
- July 16, 2015
- Posted
- August 12, 2015
- Recall Number
- Z-2373-2015
- Quantity
- 2,264,028
- Firm Location
- Waltham, MA
Reason for Recall
Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
Distribution
Nationwide Distribution
Lot / Code Info
Lots begin with: 15AMLB, 15BMLB, 15CMLB.
Root Cause
Process control
Action Taken
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.