Fresenius Medical Care Recalls Naturalyte Liquid Bicarbonate Concentrate
Fresenius Medical Care is recalling Naturalyte Liquid Bicarbonate Concentrate due to potential bacterial contamination. The recall covers 2,264,028 units distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with a risk of bacterial contamination, which aligns with the rubric criteria for Severe severity (FDA Class II with significant injury/property-damage reports or high-risk pathogens).
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottles, a dialysate concentrate used for hemodialysis. The recall involves 2,264,028 units that were distributed nationwide.
The recall was initiated due to the potential for bacterial contamination in lots manufactured in 2015. The affected lots begin with the codes 15AMLB, 15BMLB, or 15CMLB.
This is an expansion of a previous recall to include these specific 2015 lots. The source text does not specify further instructions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 2,264,028
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots begin with: 15AMLB
- 15BMLB
- 15CMLB.
Distribution
Distributed nationwide across the United States.
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