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