Recall Z-1124-2022— Devicor Medical Products Inc

Name: FDA recall Z-1124-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-30

Class II · Terminated

Class II FDA medical device recall by Devicor Medical Products Inc, initiated 2022-03-30, terminated 2024-04-30. It names one FDA 510(k) clearance: K210752. Product: HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4. 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..

Recalling firm: Devicor Medical Products Inc
Classification: Class II
Status: Terminated
Initiated: 2022-03-30
Terminated: 2024-04-30
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K210752 — HydroMARK Breast Biopsy Site MarkerDevicor Medical Products, Inc.·cleared 2021-04-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.