Recall Z-1869-2018 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Rockwell Medical, Inc
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.
| Date | Apr 7, 2018 |
| Status | Terminated |
| Reason | A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch. |
| 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 dex |
| Quantity | 139 |
| Distribution | US Distribution to the state of NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981003 | ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES International Medical Products, Inc., Jun 16, 1998 |