Device product
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.
Z-1827-2015
Product summary
- Event
- Event 71160
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,856,619 Bottles
- Official record key
device-enforcement:Z-1827-2015
Official wording
Reason: Bacterial contamination.
Code information: Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Microbial contamination
Bacterial contamination