Recall Z-2402-2020 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Diasol, Inc
DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
| Date | Apr 30, 2020 |
| Status | Terminated |
| Reason | Incorrect labeling of dialysate concentration for hemodialysis. |
| Root cause | Labeling design |
| 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. |
| Quantity | 212 Cases of 4 gallons each |
| Distribution | U.S.: CA O.U.S.:None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851431 | HEMODIALYSIS CONCENTRATE ADDITIVES Dana Laboratories, Jun 12, 1985 |