CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
DriSate¿ Product recalled by Rockwell Medical
Rockwell Medical is recalling DriSate¿ Product, distributed in New York. The recall was initiated on 7 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1869-2018
- FDA event ID
- 79878
- Recalling firm
- Rockwell Medical, Wixom, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Apr 2018
- FDA classified
- 14 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 7 Apr 2018 | Recall initiated by company | |
| 14 May 2018 | Classified by FDA | +37 days |
| 23 May 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Product as listed by the FDA
DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
Where it was distributed
US Distribution to the state of NY
Questions about this recall
Is DriSate¿ Product recalled?
Yes. Rockwell Medical recalled DriSate¿ Product on 7 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-1869-2018.
Why was it recalled?
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Which lots are affected?
Lot 28562-0220171
Where was it sold?
US Distribution to the state of NY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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