Recall Z-1869-2018— Rockwell Medical, Inc

Name: FDA recall Z-1869-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-07

Class II · Terminated

Class II FDA medical device recall by Rockwell Medical, Inc, initiated 2018-04-07, terminated 2018-10-01. It names one FDA 510(k) clearance: K981003. 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.. Reason: A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch..

Recalling firm: Rockwell Medical, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-04-07
Terminated: 2018-10-01
Firm location: Wixom, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K981003 — ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXESInternational Medical Products, Inc.·cleared 1998-06-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.

Data sourced from openFDA. This site is unofficial and independent of the FDA.