STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be use

FDA device recall Z-1180-2013 · posted 2013-04-26 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

Reason for recall

Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life.

Action taken

Advanced Sterilization Products sent an Urgent Medical Device Recall letter dated April 22 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers that have installed and validated STERRAD system between Feb 2012 and March 2013, are instructed to contact Stericycle at (888) 943-4901 to determine if their STERRAD System is eligible for an optional revalidation. If customers would like to have their system validation repeated, ASP will revalidate their system without charge. Customers are instructed that the revalidation can occur as part of a routine Planned Maintenance (PM) within 12 months. Customers are also notified that the optional procedure will require that their Sterrad System will be unavailable for use for approximately 31 hours (depending on their system) while revalidation is performed. Customers are instructed to contact Stericycle at the number above with their STERRAD System serial number by May 31 2013. Customers are instructed to contact Stericycle at (888) 943-4898 or contact their ASP representative. Stericycle's hours of operations are Mon-Fri , 8am-5pm, ET.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FRC

Quantity affected

69,994 cases

Distribution

Worldwide Distribution - Nationwide Distribution including the states of AR, AL, AK, AZ, CA, CT, CO, DE, FL, GA, HI, IA, IL, IN, ID, KY, LA, MA, ME, MD, MI, MS, MN, MO, MT, NC, ND, NE, NJ, NY, NV, NH,

Date initiated

2013-04-22

Date posted

2013-04-26

Date terminated

2013-08-01

Location

Irvine, CA