Edermy PIE Trolley System recalled for lacking FDA 510(k) clearance
Edermy LLC is recalling the PIE Trolley System, model 2005, because the device lacks 510(k) clearance from the FDA.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers voluntary precautionary recalls: the recall is for a missing regulatory clearance and the source describes no defect, malfunction or hazard in the device.
Plain-English summary
Edermy LLC is recalling the PIE Trolley System, model 2005. About 27 units were distributed in Ohio, Arizona, Illinois, Pennsylvania, Indiana, California, Missouri, Massachusetts, Minnesota, Virginia, Florida, New York, Alabama, South Carolina, North Carolina, Tennessee, Texas and Colorado. The FDA has classified this recall as Class II.
The recall was initiated for lack of 510(k) clearance. The source record does not describe a defect or malfunction in the device itself.
All lots are affected.
Facilities can identify affected devices by the model number above, and may contact Edermy LLC for further information.
The recalled product
- Product
- PIE Trolley System Model: 2005
- Manufacturer
- Edermy LLC
- Category
- Medical Device — Regulatory
- Hazard
- missing-510k
- regulatory-recall
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 Lots
Distribution
Distributed nationwide across the United States.
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