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.
Reported: July 1, 2015 Initiated: May 20, 2015 #Z-1827-2015
Product Description
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.
Reason for Recall
Bacterial contamination.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 1,856,619 Bottles
- Distribution
- Nationwide Distribution
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 1,856,619 Bottles.
Why was this product recalled? ▼
Bacterial contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2015. Severity: Moderate. Recall number: Z-1827-2015.
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