FDAClass IIDecember 25, 2019

MICRO-PSD Electron recall

MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure…

Why was MICRO-PSD Electron recalled?

May result in readings outside of the expected accuracy range.

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?

Lot Numbers: 119788 UDI: 00851546007615

Product
MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure…
Recalling firm
Angiodynamics, Inc.
Quantity
36 units
Distribution
US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
Recall date
December 25, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls