Events

Recall of Device Recall STERRAD Cyclesure Biological Indicator (BI),

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Sterilization Products.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33854
  • Event Risk Class
    Class 2
  • Event Number
    Z-2100-2012
  • Event Initiated Date
    2012-06-28
  • Event Date Posted
    2012-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110734
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Indicator, biological sterilization process - Product Code FRC
  • Reason
    Advanced sterilization products (asp) is recalling certain lots of the sterrad cyclesure 24 biological indicator (bi) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
  • Action
    ASP has posted the STERRAD CYCLESURE Biological Indicator customer letter on their external facing website at: wwww.aspjj.com/us/news/cyclesureletter on July 3, 2012. The letter informed customers who purchased STERRAD CYCLESURE 24 Biological Indicator (BI) product that Advanced Sterilization Products (ASP) is recalling certain lots because ASP has determined that it does not have adequate data to support the entire duration of the product's labeled shelf-life. The letter also provided the customers with what actions are needed for the recall. Customers were instructed to return all unused STERRAD CYCLESURE 24 BI product that exceeds the newly determined expiration dated using the enclosed prepaid UPS return label to Stericycle, 2670 Executive Drive Suite A, Indiapolis, IN 46241. Customers were instructed to count their inventory of product that exceeds the newly determined expiration date and record the data on the enclosed Business Reply Card and packing slip that are included with the customer recall letter. Customers were instructed to complete the requested information on the enclosed postage paid Business Reply Card and return it to Stericycle. Customers were instructed to contact Stericycle at (877) 907-7030 if they need additional packing labels. If customers further distribute the affected products to other locations, then they were instructed to contact Stericycle to arrange for return of the product. Customers were instructed that new shipments of STERRAD CYCLESURE 24 BI product will be shipped on July 9, 2012 that has accurate expiration dates that do not require conversion. Customers wil be able to differentiate between current product and the newly shipped product by the lot number. Current product has a lot number containing 6 characters, eg. 123456. Newly shipped product will have a lot number containing 8 characters, eg. 123456EE. Customers with any additional questions were instructed to contact (877) 907-7030 or contact their A

Device

Device Recall STERRAD Cyclesure Biological Indicator (BI),
  • Model / Serial
    Lot# 002127, 003127, 005127, 006127, 007127, 008127, 009127, 010127, 011128, 012127, 013127, 014127, 015127, 016127, 018127, 019127, 020127, 021127, 023127, 024127, 025127, 026127, 027127, 028127, 030127, 031127, 032127, 033127, 034127, 035127, 036127, 037127, 038121, 038127 039127, 040127, 041121, 042127, 043127, 044127, 045121, 045127, 046127, 047127, 048127, 049127, 052127, 053121, 053127, 054127, 055121, 056127, 057127, 058127, 059127, 060127, 061127, 062121, 062127, 063127, 064127, 065127, 067127, 068127, 069121, 069127, 070127, 071127, 072127, 073127, 074127, 076121, 077127, 078127, 078128, 079127, 081127, 082127, 084127, 085127, 086121, 086127, 087127, 089127, 090127, 092127, 093121, 094127, 095127, 100121, 100127, 101127, 102127, 104127, 107121, 107127, 107128, 109127, 109128, 110127, 111127, 114121, 114127, 118127, 121121, 121127, 123127, 124127, 125127, 128121, 128127, 129127, 130127, 131127, 132127, 135121, 135127, 136127, 137127, 138127, 139127, 142121, 142127, 143127, 144127, 145127, 146127, 150121, 150127, 151127, 152127, 152128,156127, 157127, 158127, 159127, 160127, 163127, 164127,165127, 339117, 340117, 341117, 342117, 343117, 344117, 345117, 346117, 347117, 348117, 349117, 350117, 351117, 352117, 353117, 354117, 355117, 357117, 360117, 362117, 363117, 364117.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. || 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.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • Manufacturer Address
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA