Date Initiated by Firm | April 07, 2018 |
Create Date | May 14, 2018 |
Recall Status1 |
Terminated 3 on October 01, 2018 |
Recall Number | Z-1869-2018 |
Recall Event ID |
79878 |
510(K)Number | K981003 |
Product Classification |
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
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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. |
Code Information |
Lot 28562-0220171 |
Recalling Firm/ Manufacturer |
Rockwell Medical, Inc 30142 S. Wixom Rd. Wixom MI 48393-3440
|
For Additional Information Contact | Karla Byrne 864-849-0530 |
Manufacturer Reason for Recall | A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch. |
FDA Determined Cause 2 | 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 dextrose bag. For further questions, please call (864) 849-0530. |
Quantity in Commerce | 139 |
Distribution | US Distribution to the state of NY |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KPO
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