Device product
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Z-2373-2015
Product summary
- Event
- Event 71724
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,264,028
- Official record key
device-enforcement:Z-2373-2015
Official wording
Reason: Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
Code information: Lots begin with: 15AMLB, 15BMLB, 15CMLB.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Microbial contamination
bacterial contamination