Recall Z-2016-2009
Hach Co · initiated April 21, 2009
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.
Codes / lots: Part Number: 811905, Lot Number: A8350; and Part Number: 1905LB, Lot Numbers: 8350 and 8345.
Reason for recall
Some of the reagent strip bottles contain the incorrect strips
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-2016-2009
- Initiated
- April 21, 2009
- Posted by FDA
- September 4, 2009
- Terminated
- October 7, 2009
- Product code
- LIF – Dialyzer Reprocessing System
- Quantity
- 275 kits
- Distribution
- Nationwide Distribution -- NJ, CA, IN, PA, NV, CA, and ME.
- Recalling firm
- Hach Co, Ames, IA