Medical device recall: MedicaLyte dialysis concentrate affected by foreign matter
Nipro Renal Solutions is recalling MedicaLyte Liquid Bicarbonate Concentrate dialysis solution due to potential visible foreign matter. The FDA Class I recall affects units distributed nationwide and internationally.
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: FDA Class I designation requires a minimum score of 4 per the rubric. Although no illnesses or injuries are reported in the source text, Class I is the FDA's highest classification for medical device recalls and indicates a serious health hazard. Foreign matter in a dialysis concentrate poses significant risk during renal treatment.
Plain-English summary
Nipro Renal Solutions USA, Corporation is recalling MedicaLyte Liquid Bicarbonate Concentrate, a medical device concentrate used in dialysis treatment. The recall involves two models: BC+201 (45X) and BC+100 (36.83X), packaged in plastic bottles within corrugated shipper cases.
The recall was initiated due to the potential for visible foreign matter to be present in the product. MedicaLyte Liquid Bicarbonate Concentrate is used to prepare dialysate solutions for renal replacement therapy, and contamination with foreign material could compromise treatment safety.
The recall affects approximately 816,840 units of model BC+201 and 39,228 units of model BC+100 distributed nationwide across 28 states including Arizona, California, Colorado, and others, as well as Puerto Rico, Guatemala, and Panama. Specific lot numbers for BC+100 are identified as N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, and N5A044.
Consumers and healthcare providers with affected units should discontinue use and contact Nipro Renal Solutions USA, Corporation for guidance on replacement or proper disposition of the product. The FDA has classified this as a Class I recall, indicating a serious health hazard.
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
- Hazard
- foreign-matter
- contamination
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
Distributed nationwide across the United States.
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