Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Reported: August 19, 2015 Initiated: July 16, 2015 #Z-2373-2015
Product Description
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Reason for Recall
Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 2,264,028
- Distribution
- Nationwide Distribution
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 2,264,028.
Why was this product recalled? ▼
Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 19, 2015. Severity: Moderate. Recall number: Z-2373-2015.
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