FDA recall Z-1124-2022

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2022-03-30

Report date

2022-06-01

Termination date

2024-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1124-2022