The Recall Desk
HighFDA (Devices)·Z-1266-2016·Announced 2016-04-06

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.

What this means for you

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
Category
Medical Device — Sterilization Equipment
Hazard
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

Distributed in 8 states:

Related recalls

Same hazard · sterility compromise

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