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Recall Observatory FDA recall evidence

Device product

HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

Z-1124-2022

March 30, 2022

Class II

Product summary

Firm
Devicor Medical Products Inc
Event
Event 90119
Status
Terminated
Classification
Class II
Quantity
90 devices
Official record key
device-enforcement:Z-1124-2022

Official wording

Reason: 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.

Code information: UDI-DI: 00841911102472 Lot F12201281D

Distribution pattern: US Nationwide distribution in the states of DE, KY, NY, OH, WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.