Recall Z-2016-2009 ยท LIF Dialyzer Reprocessing System
Hach Co
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.
| Date | Sep 4, 2009 (initiated Apr 21, 2009) |
| Status | Terminated |
| Reason | Some of the reagent strip bottles contain the incorrect strips |
| Root cause | 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 | 275 kits |
| Distribution | Nationwide Distribution -- NJ, CA, IN, PA, NV, CA, and ME. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974798 | STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS Environmental Test Systems, Inc., Mar 20, 1998 |