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Recall Observatory FDA recall evidence

Device product

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

Z-2111-2012

July 09, 2012

Class II

Product summary

Firm
Beekley Corporation
Event
Event 62526
Status
Terminated
Classification
Class II
Quantity
267,332 units
Official record key
device-enforcement:Z-2111-2012

Official wording

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

Code information: Lot Numbers: A036, A037, A038, A039, A040, A041, A042, A044, A045, A046

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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