Edermy PIE PAK units recalled for lacking FDA 510(k) clearance
Edermy LLC is recalling PIE PAK models P2HC-A, P2HC-S and P2HC because the devices lack 510(k) clearance from the FDA.
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 2/5 (Moderate).
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 PAK, models P2HC-A, P2HC-S and P2HC. About 11,202 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 numbers above, and may contact Edermy LLC for further information.
The recalled product
- Product
- PIE PAK Models: P2HC-A, P2HC-S, P2HC
- Manufacturer
- Edermy LLC
- Category
- Medical Device — Regulatory
- Affected units
- 11,202
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 UDI:
Distribution
Part of a larger recall action
This product is one of 2 recalled by Edermy LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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See all →- ModerateEdermy PIE Trolley System recalled for lacking FDA 510(k) clearance
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