STERRAD NX Sterilizer Hydrogen Peroxide Gas Plasma Sterilizer Product Code 10133. The STERRAD Sterilization System is a
FDA device recall Z-0468-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX System Cassettes 10133, Lot #08I032. This is the only lot number affected by this action. The barcodes for Lot #08I032 were printed improperly and are not capable of being read by the STERRAD unit.
- Action taken
- Advance Sterilization Products sent an "URGENT: PRODUCT RECALL" letter dated December 10, 2008 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to examine inventory and return all sealed cassettes, using an enclosed prepaid UPS return label to: Stericycle, 2670 Executive Drive Suite A, Indianapolis, IN 46241. Additionally, a Business Reply Card and packing slip were included with the letter for customers to complete and return. Questions or further assistance was directed to ASP Customer Care Center at 888-783-7723, option 2.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 776 cases
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-12-10
- Date posted
- 2012-01-11
- Date terminated
- 2011-12-16
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERRAD NX STERILIZER (K042116) | Advanced Sterilization Products | 2005-04-22 |