Reported Jun 1, 2022 · Terminated
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Devicor Medical Products Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Devicor Medical Products Inc · 300 E Business Way Fl 5 · Cincinnati, OH · 45241-2384
Is this the product you have?
- HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
- Lot codes and dates
- UDI-DI00841911102472 Lot F12201281D
- Amount recalled
- 90 devices
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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