S-SPOT recall
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
Why was S-SPOT recalled?
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
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?
REF 777 - Lot Numbers: 02281802 05301801 04041801 04211801 03301801 05101802 05241801 02191801 03151801 03281801 04281801 02131802 REF 777S - Lot Numbers
- Product
- S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
- Recalling firm
- Beekley Corporation
- Quantity
- 3,384,024 pieces in total.
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.
- Recall date
- August 22, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)