Steris Corporation: Medical Device Recall in 2012 - (Recall #: Z-2325-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: August 2, 2012

Date Posted: September 12, 2012

Recall Number: Z-2325-2012

Event ID: 62852

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.

Status: Terminated

Product Quantity: 77 packs

Code Information:

Product code KCT; Lot number: 60263

Distribution Pattern:

Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, IL, IN, KY, LA, MO, MS, NJ, OH, PA, SD, TX, and VA., and the countries of Japan, Peru, and Suriname.

Voluntary or Mandated:

Voluntary: Firm initiated