Device product
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part 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.
Z-1739-2014
Product summary
- Event
- Event 68135
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12 bottles
- Official record key
device-enforcement:Z-1739-2014
Official wording
Reason: Container cap may contain foreign material- 0.60% - 0.80% Manganese
Code information: Lot Number: 14CMLB006
Distribution pattern: Distributed in the state of MO.
Derived failure modes
-
Foreign material or chemical contamination
foreign material