Z-1869-2018 Class II Terminated
FDA device recall Z-1869-2018 was initiated by Rockwell Medical, Inc on April 7, 2018 and is designated Class II. Reason for recall: A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch. The recall status is terminated (terminated October 1, 2018). Affected quantity: 139.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- April 7, 2018
- Termination Date
- October 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139
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.
Distribution Pattern
US Distribution to the state of NY
Code Information
Lot 28562-0220171