The S.C.O.R.E.S. Unit recall: Sterility Concern
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
Why was The S.C.O.R.E.S. Unit recalled?
Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ALL distributed S.C.O.R.E.S. units are affected.
- Product
- The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
- Recalling firm
- PMBS, LLC
- Quantity
- 58 units
- Distribution
- FL, GA, MN, NY, OH, OR SC, and TN
- Recall date
- April 6, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)