Z-1124-2022 Class II Terminated
FDA device recall Z-1124-2022 was initiated by Devicor Medical Products Inc on March 30, 2022 and is designated Class II. 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 pro… The recall status is terminated (terminated April 30, 2024). Affected quantity: 90 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 1, 2022
- Initiation Date
- March 30, 2022
- Termination Date
- April 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 devices
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.
Distribution Pattern
US Nationwide distribution in the states of DE, KY, NY, OH, WV.
Code Information
UDI-DI: 00841911102472 Lot F12201281D