Home / Recalls / Beekley Corporation / Z-2830-2018

Z-2830-2018 Class II Terminated

Recalled by Beekley Corporation — Bristol, CT

Recall Details

Product Type
Devices
Report Date
August 22, 2018
Initiation Date
June 13, 2018
Termination Date
November 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,384,024 pieces in total.

Product Description

O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.

Reason for Recall

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

Distribution Pattern

Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.

Code Information

REF 791 - Lot Numbers: 05311802 03051802 03271802 04191801 04031801 04241801 04231801 03291802 04021801 02271801 05291802 03081801 03091801 05111801 05251801 04091801 02201801 02231801 02071801 02091801 03161802 03231801 02131801 05031801 03011801 03291801 04301801 05171801 04161801 04261801 02051801 04051801 03201801 03221801 02151801 03221802 02021801 05231802 05021801 04191802 05291801 04301802 05211802 02191802 REF 791S - Lot Numbers: 03191801 02221802

Other recalls by Beekley Corporation

  • Z-2832-2018 Class II — TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for (June 13, 2018)
  • Z-2831-2018 Class II — S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mam (June 13, 2018)
  • Z-2309-2017 Class III — Beekley Medical 0-SPOT Mammography Skin Markers REF 652 (May 8, 2017)
  • Z-1787-2014 Class III — Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Produc (June 19, 2013)
  • Z-2109-2012 Class II — Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammog (July 9, 2012)
  • Z-2111-2012 Class II — Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammog (July 9, 2012)
  • Z-2112-2012 Class II — Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed (July 9, 2012)
  • Z-2110-2012 Class II — Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammog (July 9, 2012)
  • Z-2080-2012 Class II — Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, (July 2, 2012)