Product Safety Recalls

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Devicor Medical Products Inc Recall 90119

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

Devicor Medical Products Inc Recall 90119 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1124-2022
Event ID90119
Event DescriptionHydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Product TypeDevices
DistributionUS Nationwide distribution in the states of DE, KY, NY, OH, WV.
Quantity90 devices
Recall ReasonSmall 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.
Device Classification20220601
Device Code InfoUDI-DI: 00841911102472 Lot F12201281D
Center Classification Date20220523
Recall Initiation Date20220330
Recalling FirmDevicor Medical Products Inc
Initial Notification E-Mail
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