STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low tempe
FDA device recall Z-0744-2014 · posted 2014-01-14 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.
- Action taken
- Advanced Sterilization Products (ASP) sent an Urgent Medical Device Field Safety Notification dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the customer response forms. Customers with questions were also instructed to contact ASP Professional Services directly at (888) 783-7723 and select option number 2. For questions regarding this recall call 949-453-6400.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 5584 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-12-16
- Date posted
- 2014-01-14
- Date terminated
- 2014-03-27
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERRAD NX STERILIZER (K042116) | Advanced Sterilization Products | 2005-04-22 |
| STERRAD 50 & STERRAD 100S STERILIZERS (K023290) | Advanced Sterilization Products | 2003-04-03 |