Home / Recalls / Beekley Corporation / Z-2831-2018

Z-2831-2018 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

S-SPOT REF 777, 777S 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 777 - Lot Numbers: 02281802 05301801 04041801 04211801 03301801 05101802 05241801 02191801 03151801 03281801 04281801 02131802 REF 777S - Lot Numbers

Other recalls by Beekley Corporation

  • Z-2830-2018 Class II — O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mam (June 13, 2018)
  • Z-2832-2018 Class II — TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for (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)