Enforcement Report - Week of September 19, 2012
-
Back to Previous Page
Product Detail
| Product Description | STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model. |
|---|---|
| Recall Number | Z-2337-2012 |
| Classification | Class III |
| Code Info | Product Code: 10113 |
| Product Distributed Qty | 7,495 units |
| Reason For Recall | Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing. |
Event Detail
| Event Id | 62925 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Advanced Sterilization Products |
| City | Irvine |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-19 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution. |
-
