Z-1266-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2016
- Initiation Date
- January 13, 2016
- Termination Date
- September 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58 units
Product Description
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
Reason for Recall
Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
Distribution Pattern
FL, GA, MN, NY, OH, OR SC, and TN
Code Information
ALL distributed S.C.O.R.E.S. units are affected.