FDAFDA · Food and drugs·Recall number Z-2831-2018
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
Published August 22, 2018 · Recall initiated: June 13, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beekley Corporation
- Distributor
- Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.
- Lot
- REF 777 - Lot Numbers: 02281802 05301801 04041801 04211801 03301801 05101802 05241801 02191801 03151801 03281801 04281801 02131802 REF 777S - Lot Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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