FDA Medical Device Recalls (openFDA)
Diasol, Inc: Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Recall number
- Z-0989-2026
- Recalling firm
- Diasol, Inc
- Product
- Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Status
- Open, Classified
- Initiated
- 2025-11-05
- Posted
- 2025-12-23
- Terminated
- not on file
- Reason
- Safety and efficacy of dialysis acid concentrate cannot be assured
- Root cause
- Process design
- Action
- On November 5, 2025, Diasol issued a "Urgent Medical Device Recall Notification to affected consignees. In addition to informing consignees about the recall, Diasol asked consignees to take the following actions: 1. Please return all product you have at your facility. 2. Please complete the attached acknowledgement form. 3. If product has been further distributed to other distributors, customer or sites, notify those consignees and provide them with a copy of the recall notification. 4. The notice should be provided to all staff members who use the product. 5. In the event you have not received adequate products from Rockwell you may continue to use Diasol Products at risk.
- Quantity
- 4400 gallons
- Distribution
- US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
- Lot, serial or model codes
- UDI: None/Lot Code: PHV08112,PHV10082
- 510(k) numbers
- ["K851431"]
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 3007137482
- Firm city
- Phoenix
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28