Fresenius NaturaLyte Liquid Bicarbonate Concentrate Recalled for Bacterial Contamination
Fresenius Medical Care is recalling NaturaLyte Liquid Bicarbonate Concentrate due to bacterial contamination. The product is used in hemodialysis machines.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 bacterial contamination in a medical device used for hemodialysis, which poses a significant risk of serious injury or death if used.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling NaturaLyte Liquid Bicarbonate Concentrate (Catalog Number: 08-4000-LB) due to bacterial contamination. This product is a dialysate concentrate for hemodialysis, formulated for use with three steam hemodialysis machines calibrated for acid and bicarbonate concentrates.
The recall affects 1,856,619 bottles distributed nationwide. Affected lots begin with the following codes: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 1,856,619
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 (9)
- Affected lots begin with: 14DMLB
- 14EMLB
- 14HMLB
- 14JMLB
- 14KMLB
- 14LMBL
- 14NMLB
- 14PMLB
- and 14SMLB.
Distribution
Distributed nationwide across the United States.
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