FDA Enforcement
Class II
Terminated
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
Recall: Z-1266-2016
·
Reported April 6, 2016
Enforcement
- Recall Number
- Z-1266-2016
- Event ID
- 73157
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- PMBS, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 6, 2016
- Initiation Date
- January 13, 2016
- Classification Date
- March 25, 2016
- Termination Date
- September 27, 2017
- Address
- 40 Milltown Rd, N/A, Stockton, NJ, 08559-1303, United States
Description
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
Reason
Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
Code Info
ALL distributed S.C.O.R.E.S. units are affected.
Distribution
FL, GA, MN, NY, OH, OR SC, and TN
Quantity
58 units