PMBS S.C.O.R.E.S. Unit Recall Due to Potential Sterility Compromise
PMBS, LLC is recalling 58 S.C.O.R.E.S. Units because water retention in filters may compromise sterility. The units were distributed to seven states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect (water retention) may compromise sterility, posing a risk of harm (infection) without reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
PMBS, LLC is recalling 58 units of the S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit). The recall was initiated because water retention issues in the units' filters may remain wet after the sterilization process, which could compromise sterility.
The affected units were distributed in Florida, Georgia, Minnesota, New York, Ohio, Oregon, South Carolina, and Tennessee. All distributed S.C.O.R.E.S. units are affected by this recall.
Consumers and healthcare facilities should stop using the affected units and contact PMBS, LLC for further instructions on the recall.
The recalled product
- Product
- The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
- Manufacturer
- PMBS, LLC
- Affected units
- 58
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ALL distributed S.C.O.R.E.S. units are affected.
Distribution
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