HydroMARK Breast Biopsy Marker recall
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Why was HydroMARK Breast Biopsy Marker 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00841911102472 Lot F12201281D
- Product
- HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
- Recalling firm
- Devicor Medical Products Inc
- Quantity
- 90 devices
- Distribution
- US Nationwide distribution in the states of DE, KY, NY, OH, WV.
- Recall date
- June 1, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)