Recall Z-1124-2022 ยท NEU Marker, Radiographic, Implantable
Devicor Medical Products Inc
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
| Date | Mar 30, 2022 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling Change Control |
| Action | On March 30, 2022, the firm distributed Urgent Medical Device Recall letters to their customers via email. Customers were informed of the labeling issue. Users were instructed to examine their inventory and identify any affected product. Users should contact their local sales representative for correction of any affected devices. The sales representative will be on site to remove the affected patient labels. Please do not use affected patient labels from this lot. If you have any additional questions, comments or concerns please contact the firm's Customer Support at +1 877-926-2666. You may |
| Quantity | 90 devices |
| Distribution | US Nationwide distribution in the states of DE, KY, NY, OH, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210752 | HydroMARK Breast Biopsy Site Marker Devicor Medical Products, Inc., Apr 14, 2021 |