MedicaLyte Liquid Bicarbonate Concentrate Recalled for Foreign Matter
Nipro Renal Solutions USA is recalling MedicaLyte Liquid Bicarbonate Concentrate (models BC+201 and BC+100) due to the potential presence of visible foreign matter in the product.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: This is an FDA Class I recall for a medical device with potential for visible foreign matter contamination. Per the severity rubric, FDA Class I recalls receive a minimum score of 4 (Severe), as they represent a serious health hazard.
Plain-English summary
Nipro Renal Solutions USA, Corporation is recalling MedicaLyte Liquid Bicarbonate Concentrate in two model numbers: BC+201 (45X) and BC+100 (36.83X). The products are packaged in plastic bottles within corrugated shipper cases containing 4 bottles per case. The recall is due to the potential for the presence of visible foreign matter in the product.
The recalled products have been distributed nationwide in 28 U.S. states and Puerto Rico, as well as internationally to Guatemala and Panama. Model BC+201 (45X) includes 816,840 units, and Model BC+100 (36.83X) includes 39,228 units. Specific lot numbers are identified for Model BC+100 (N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, N5A044), while all lot numbers of Model BC+201 are affected.
Consumers and healthcare facilities currently using or possessing these products should stop use immediately. For questions or to report any adverse events related to use of this product, consumers should contact Nipro Renal Solutions USA, Corporation or their healthcare provider.
The recalled product
- Product
- MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).
- Manufacturer
- Nipro Renal Soultions USA, Corporation
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 (11)
- a. Model Number: BC+201 (45X). Case UDI-DI: 10817411022821
- Bottle UDI-DI 00817411022817. Lot Numbers: N3C014
- N3C018
- N3F018
- N4C010
- N4C012
- N4E004
- N4L021
- N4L022
- N4L037
- N5A044.
Distribution
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