HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Reported: June 1, 2022 Initiated: March 30, 2022 #Z-1124-2022
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.
Details
- Recalling Firm
- Devicor Medical Products Inc
- Units Affected
- 90 devices
- Distribution
- US Nationwide distribution in the states of DE, KY, NY, OH, WV.
- Location
- Cincinnati, OH
Frequently Asked Questions
What product was recalled? ▼
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4. Recalled by Devicor Medical Products Inc. Units affected: 90 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 1, 2022. Severity: Moderate. Recall number: Z-1124-2022.
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