Z-1869-2018Class II

DriSate Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and...

Name: Z-1869-2018 DriSate Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and...
Creator: Rockwell Medical, Inc
Published: 2018-04-07
License: https://open.fda.gov/license/

Rockwell Medical / initiated 2018-04-07 / Terminated / root cause: manufacturing process

FDA source

Rockwell Medical, Inc began a recall of 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... on 2018-04-07. FDA classified it as Class II and gives the reason as "A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1869-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-07
Posted: 2018-05-14
Terminated: 2018-10-01
Recalling firm: Rockwell Medical
Product: 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.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Removal notification involved one customer and two facilities. The two facilities receiving the DR-145 kit lot were contacted directly via phone, email, and issuance of a RGA to return the product. Stock retrieval was completed by 4/7/17. See attached email and RGA. Communication was already completed and stock was retrieved. Discard and/or return via RGA provided The complaint documented a stock reconciliation in the complaint and all units were accounted for. The two customer facilities involved responded directly Affected kits were reworked to remove and replace the nonconforming dextrose bag. For further questions, please call (864) 849-0530.
Quantity in commerce: 139
Distribution: US Distribution to the state of NY
Product codes and lots: Lot 28562-0220171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1869-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1869-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-14

Product code KPO

K981003Class IIRockwell Medical Supply, Llc. Dri-Sate Acid Concentrate MixesInternational Medical Products, Inc. / cleared 1998-06-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)