Z-1266-2016 Class II Terminated
FDA device recall Z-1266-2016 was initiated by PMBS, LLC on January 13, 2016 and is designated Class II. Reason for recall: Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility. The recall status is terminated (terminated September 27, 2017). Affected quantity: 58 units.
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.