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Terminated

Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern

FDA Recall Z-2111-2012 · Posted 2012-07-31

Recalling FirmBeekley Corporation
Recall StatusTerminated
Product CodeJAC
Date Initiated2012-07-09
Date Terminated2013-07-09
Product Quantity267,332 units

Reason for Recall

Digital Skin Mammography Marker separating from the backing of the spot material

Firm Action

Beekley Medical issued an Urgent Medical Device Recall letter dated July 9, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were advised to contact Beekley Medical's Customer Service Team at 1-800-233-5539 to return affected lots for replacement. Customers were instructed to complete and return the attached reply form.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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