FDAClass IIIJune 14, 2017

Beekley Medical 0-SPOT Mammography Skin Markers recall

Beekley Medical 0-SPOT Mammography Skin Markers REF 652

Why was Beekley Medical 0-SPOT Mammography Skin Markers recalled?

Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels

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 652.04251701

Product
Beekley Medical 0-SPOT Mammography Skin Markers REF 652
Recalling firm
Beekley Corporation
Quantity
104 boxes (58/box)= 6,032 total units
Distribution
US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.
Recall date
June 14, 2017
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls