Z-1011-2017 Class II Terminated

Recalled by Symmetry Surgical, Inc. — Antioch, TN

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