Dialysis concentrate 100325 recalled because safety and efficacy cannot be assured
Diasol is recalling 74,400 gallons of liquid concentrate for bicarbonate dialysis, product 100325-10-DEX100, because the safety and efficacy of the dialysis acid concentrate cannot be assured.
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 3/5 (High).
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 100325-10-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 74,400 gallons, from lot codes PHV07221, PHV07241, PHV07291, PHV08182, PHV08201, PHV08221, PHV08271, PHV09031 and PHV09051 among others. 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: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Manufacturer
- Diasol, Inc
Distribution
Part of a larger recall action
This product is one of 6 recalled by Diasol, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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