HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
FDA Recall Z-1124-2022 · Posted None
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Recalling FirmDevicor Medical Products Inc
Recall StatusTerminated
Product CodeNEU
Date Initiated2022-03-30
Date Terminated2024-04-30
Product Quantity90 devices
Reason for Recall
Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Firm Action
On March 30, 2022, the firm distributed Urgent Medical Device Recall letters to their customers via email. Customers were informed of the labeling issue. Users were instructed to examine their inventory and identify any affected product. Users should contact their local sales representative for correction of any affected devices. The sales representative will be on site to remove the affected patient labels. Please do not use affected patient labels from this lot.
If you have any additional questions, comments or concerns please contact the firm's Customer Support at +1 877-926-2666. You may also email [email protected].
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution in the states of DE, KY, NY, OH, WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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