Dialysis concentrate 100220 recalled because safety and efficacy cannot be assured
Diasol is recalling 4400 gallons of liquid concentrate for bicarbonate dialysis, product 100220-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states the safety of a dialysis concentrate cannot be assured, and no injuries are reported.
Plain-English summary
Diasol 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters, is being recalled.
The reason given in the enforcement record is that the safety and efficacy of the dialysis acid concentrate cannot be assured.
The record lists 4400 gallons, from lot codes PHV08112, PHV10082. Distribution was nationwide in the United States, in Missouri, California, Arizona, Texas, Illinois and Massachusetts. The FDA has classified the action as Class II.
Dialysis concentrate is prepared into the fluid a patient is dialysed against. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Diasol's instructions.
The recalled product
- Product
- Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Manufacturer
- Diasol, Inc
- Hazard
- unassured-safety
- dialysis
- concentrate
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 (2)
- UDI: None/Lot Code: PHV08112
- PHV10082
Distribution
Distributed nationwide across the United States.
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