DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
This recall has been terminated (originally issued April 30, 2020).
- Company
- Diasol, Inc
- Recall Initiated
- April 30, 2020
- Terminated
- May 28, 2024
- Recall Number
- Z-2402-2020
- Quantity
- 212 Cases of 4 gallons each
- Firm Location
- Phoenix, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect labeling of dialysate concentration for hemodialysis.
Distribution
U.S.: CA O.U.S.:None
Lot / Code Info
Model Number: 100225-10-DEX100 Gallons Unique Device Identifier (UDI): B467100225101004 and B4671000225101004 Lot codes if applicable: PHQ03041/030920
Root Cause
Labeling design
Action Taken
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.