FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2016-2009
- Recalling firm
- Hach Co
- 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.
- Status
- Terminated
- Initiated
- 2009-04-21
- Posted
- 2009-09-04
- Terminated
- 2009-10-07
- 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.
- Lot, serial or model codes
- Part Number: 811905, Lot Number: A8350; and Part Number: 1905LB, Lot Numbers: 8350 and 8345.
- 510(k) numbers
- ["K974798"]
- PMA numbers
- not on file
- Product code
- LIF
- Firm FEI
- 1000518597
- Firm city
- Ames
- Firm state
- IA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28