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Recall Observatory FDA recall evidence

Device 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.

Z-2325-2012

August 02, 2012

Class III

Product summary

Firm
Steris Corporation
Event
Event 62852
Status
Terminated
Classification
Class III
Quantity
77 packs
Official record key
device-enforcement:Z-2325-2012

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.