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
Product summary
- 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
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.