DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
FDA Recall Z-2402-2020 · Posted None
Recalling FirmDiasol, Inc
Recall StatusTerminated
Product CodeKPO
Date Initiated2020-04-30
Date Terminated2024-05-28
Product Quantity212 Cases of 4 gallons each
Reason for Recall
Incorrect labeling of dialysate concentration for hemodialysis.
Firm Action
On 04/30/2020, the firm called customers informing them of the labeling error and instructed customers to:
-Check if they have any remaining stock
-Discontinue use of the specific lot
-See if there have been any adverse events if used
On 05/01/2020 the firm sent an "URGENT: MEDICAL DEVICE RECALL" to customers via certified mail informing them of the above and to contact customer service at (602) 442-7670 to arrange pickup of any stock of this lot number and replacement of a different lot number will be provided.
For questions, contact Customer Service at (602) 442-7670.
Root Cause
Labeling design
Distribution Pattern
U.S.: CA O.U.S.:None
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.