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U.S. Department of Health and Human Services

Class 2 Device Recall Mole markers

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  Class 2 Device Recall Mole markers see related information
Date Initiated by Firm June 13, 2018
Create Date August 16, 2018
Recall Status1 Terminated 3 on November 13, 2018
Recall Number Z-2830-2018
Recall Event ID 80558
Product Classification System, x-ray, film marking, radiographic - Product Code JAC
Product O-SPOT REF 791, 791S

Adhere to skin for marking and identifying moles in mammography.
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  
Recalling Firm/
Manufacturer		 Beekley Corporation
1 Prestige Ln
Bristol CT 06010-7468
For Additional Information Contact
860-583-4700
Manufacturer Reason
for Recall		 There is a potential for imaging artifact to mimic calcifications on patient's mammograms
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On June 14, 2018, Beekley Medical issued an "URGENT MEDICAL DEVICE RECALL" notice dated June 13, 2018 to customers. The notice described the products, problem and actions to be taken. Customers are advised to do the following: - Inspect stock and quarantine affected product - complete and return the acknowledgement response form via fax to: 1-800-735-1234 or mail. - contact firm if inventory of affected product remains with customers at 1-800-233-5539 between 8:00am - 5:30pm EDT. If you have any issues occurred or for further question, contact Quality Assurance & Regulatory Manager at 1-800-233-5539x434.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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