Z-1011-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2017
- Initiation Date
- November 29, 2016
- Termination Date
- August 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149 units
Product Description
symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP, C24136-SP, C24138-SP Product Usage: sterilization container
Reason for Recall
Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.
Distribution Pattern
Worldwide Distribution
Code Information
All