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U.S. Department of Health and Human Services

Class 2 Device Recall HACH SteriChek Residual Peroxide Reagent Strips

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  Class 2 Device Recall HACH SteriChek Residual Peroxide Reagent Strips see related information
Date Initiated by Firm April 21, 2009
Date Posted September 04, 2009
Recall Status1 Terminated 3 on October 07, 2009
Recall Number Z-2016-2009
Recall Event ID 51966
510(K)Number K974798  
Product Classification Dialyzer reprocessing system - Product Code LIF
Product HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hach Co., Ames, IA.

SteriChek Residual Peroxide Reagent Strips provide a convenient means of measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.
Code Information Part Number: 811905, Lot Number: A8350; and Part Number: 1905LB, Lot Numbers: 8350 and 8345.
Recalling Firm/
Manufacturer		 Hach Co
100 Dayton Ave
Ames IA 50010-6402
For Additional Information Contact John Nelson
440-498-2579
Manufacturer Reason
for Recall		 Some of the reagent strip bottles contain the incorrect strips
FDA Determined
Cause 2		 Labeling mix-ups
Action Hach Company issued an "Urgent Medical Device Recall" letter dated April 21, 2009 explaining the reason for recall and requested product remaining in inventory be returned. Subrecall to the end-user level was requested. A Return Form was also enclosed to be completed to indicate the amount of product being returned. Between April 22-23, 2009, the firm telephoned their customers to assure they received the recall letter. For further information, contact Hach Customer Service at 1-800-548-4381 extension 3560.
Quantity in Commerce 275 kits
Distribution Nationwide Distribution -- NJ, CA, IN, PA, NV, CA, and ME.
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 = LIF and Original Applicant = ENVIRONMENTAL TEST SYSTEMS, INC.
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