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.
FDA Recall Z-2016-2009 · Posted 2009-09-04
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Recalling FirmHach Co
Recall StatusTerminated
Product CodeLIF
Date Initiated2009-04-21
Date Terminated2009-10-07
Product Quantity275 kits
Reason for Recall
Some of the reagent strip bottles contain the incorrect strips
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution -- NJ, CA, IN, PA, NV, CA, and ME.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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