STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation

FDA device recall Z-2100-2012 · posted 2012-07-27 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

Reason for recall

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 taken

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

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

FRC

Quantity affected

38,693 units

Distribution

Worldwide Distribution - USA (nationwide)

Date initiated

2012-06-28

Date posted

2012-07-27

Date terminated

2013-08-13

Location

Irvine, CA

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