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Terminated

Sterrad CycleSure Biological Indicator, Product Code 14324. The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cycles.

FDA Recall Z-0066-2010 · Posted 2009-10-20

Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeFRC
Date Initiated2009-06-23
Date Terminated2011-11-29

Reason for Recall

Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time.

Firm Action

An Important Product Labeling Correction - New Instructions for Use dated, June 26, 2009, has been proposed to be sent by the firm for Cyclosure Biological Indicators to consignees. The revised instructions reduce the maximum read time for the indicators to 3 days (72 hours). The letter also states why ASP changed the Instructions. Questions are to be directed to ASP Customer Care Center.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031226STERRAD CYCLESURE BIOLOGICAL INDICATORAdvanced Sterilization Products · 2003-05-02K994055STERRAD CYCLESURE BIOLOGICAL INDICATORAdvanced Sterilization Products · 2002-02-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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