FDA recall Z-1869-2018

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 for recall

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

Distribution

US Distribution to the state of NY

Key facts

Status

Terminated

Initiation date

2018-04-07

Report date

2018-05-23

Termination date

2018-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wixom, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1869-2018