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.
This recall has been terminated (originally issued June 9, 2014).
- Recall Initiated
- May 1, 2014
- Posted
- June 9, 2014
- Terminated
- June 15, 2016
- Recall Number
- Z-1739-2014
- Quantity
- 12 bottles
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Container cap may contain foreign material- 0.60% - 0.80% Manganese
Distribution
Distributed in the state of MO.
Lot / Code Info
Lot Number: 14CMLB006
Root Cause
Equipment maintenance
Action Taken
Fresenius Medical notified customer by letter dated 5/1/14 to examine stock immediately and instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to FMC-RTG. The customer instructed to contact the Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product.
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