Recall Z-2325-2012— Steris Corporation

Name: FDA recall Z-2325-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-02

Class III · Terminated

Class III FDA medical device recall by Steris Corporation, initiated 2012-08-02, terminated 2013-09-04. It names one FDA 510(k) clearance: K092745. Product: 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.. Reason: On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators..

Recalling firm: Steris Corporation
Classification: Class III
Status: Terminated
Initiated: 2012-08-02
Terminated: 2013-09-04
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K092745 — VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TUSTERIS Corporation·cleared 2010-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.

Reason for recall

On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.

Data sourced from openFDA. This site is unofficial and independent of the FDA.