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U.S. Department of Health and Human Services

Class 2 Device Recall DriSate

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  Class 2 Device Recall DriSate see related information
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
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
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.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = INTERNATIONAL MEDICAL PRODUCTS, INC.
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