Reported Dec 19, 2012 · Terminated

STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI…

Advanced Sterilization Products

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Advanced Sterilization Products · 33 Technology Dr · Irvine, CA · 92618-2346

Is this the product you have?

  • STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits
  • with Sterrad Cyclesure 24 BI productsCodes/Serial Numbers
  • Product Description14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles
Lot codes and dates
  • Lot

    817 of 817 codes

    • 225117
    • 337117
    • 295117
    • 334117
    • 227117
    • 338117
    • 296117
    • 326117
    • 227118
    • 264117
    • 300117
    • 327117
    • 230117
    • 265117
    • 301117
    • 330117
    • 233117
    • 266117
    • 302117
    • 331117
    • 235117
    • 267117
    • 310117
    • 331118
    • 235118
    • 268117
    • 311117
    • 332117
    • 237117
    • 269117
    • 312117
    • 335117
    • 239117
    • 270117
    • 313117
    • 341111
    • 241117
    • 273117
    • 314117
    • 343111
    • 242117
    • 275117
    • 315117
    • 348111
    • 243117
    • 277117
    • 316117
    • 350111
    • 244117
    • 278117
    • 317117
    • 245117
    • 280117
    • 318117
    • 246117
    • 281117
    • 319117
    • 249117
    • 282117
    • 321111
Amount recalled
38,532 units

Where it was sold

Why it was recalled

Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) manufactured between February 2008 and December 2011 because it may not have adequate data to support the entire duration of the labeled shelf-life.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 19, 2013 · Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.