Enforcement Report - Week of September 12, 2012
-
Back to Previous Page
Product Detail
| 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. |
|---|---|
| Recall Number | Z-2325-2012 |
| Classification | Class III |
| Code Info | Product code KCT; Lot number: 60263 |
| Product Distributed Qty | 77 packs |
| 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. |
Event Detail
| Event Id | 62852 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Steris Corporation |
| City | Mentor |
| State | OH | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-02 |
| Initial Firm Notification of Consignee or Public | Letter |
| 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. |
-
