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Terminated

Beekley Medical 0-SPOT Mammography Skin Markers REF 652

FDA Recall Z-2309-2017 · Posted None

Recalling FirmBeekley Corporation
Recall StatusTerminated
Product CodeJAC
Date Initiated2017-05-08
Date Terminated2017-06-20
Product Quantity104 boxes (58/box)= 6,032 total units

Reason for Recall

Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels

Firm Action

Beekley Medical issued letter dated May 8, 2017 advised user of the problem and to examine inventory and return product.C Accounts requested to complete response form . Questions: Quality Assurance & Regulatory Manager at 1-800-233-5539 x 434.

Root Cause

Employee error

Distribution Pattern

US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.

Official Source

View FDA Recall →

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

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