Device Recall Sterrad Cyclesure 24 Biological Indicator 의 리콜

Recall

61954

Class 2

Z-1773-2012

2012-02-17

2012-06-06

Terminated

United States

2013-10-17

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109572

The recall was initiated by advanced sterilization products because they recently determined that certain lots of raw materials that were rejected during incoming inspection acceptance test were used for the manufacture of a specific lot range of sterrad cyclesure 24 biological indicator.

Advanced Sterilization Products a Johnson & Johnson company sent an Urgent Product Recall letter dated March 16, 2012, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to read the "Details on the Affected Devices/Description of the problem" section in the letter. Customers were instructed to immediately identify and set aside all product listed above in a manner that ensures product will not be used. The lot number and the part number are printed on the label placed around the ampoules. Customers were instructed to return any affected product in accordance with the "Product Return Instructions" section of the letter. Customers were instructed to complete the requested information on the enclosed postage paid business reply card and return it to Stericycle even if they do not have the affected products listed on the letter in stock. Customers with questions were instructed to contact Stericycle at (877) 492-4795. For questions regarding this recall call 949-453-6400.