Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
This recall is currently active, issued June 29, 2023. It was issued by Hologic, Inc.
- Company
- Hologic, Inc
- Recall Initiated
- May 2, 2023
- Posted
- June 29, 2023
- Recall Number
- Z-2035-2023
- Quantity
- 756 units
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Distribution
US Nationwide distribution.
Lot / Code Info
UDI-DI: 15420045504066 Lot Number: E22H19RM
Root Cause
Device Design
Action Taken
Hologic issued Urgent Medical Device Correction letter on 5/2/23. Letter states reason for recall, health risk and action to take: " Please properly dispose of any product(s) from this lot you currently have in your inventory. You will be issued a credit on your account for the affected product(s). If you wish to reorder product, please place a new order via your preferred procurement method. " Complete the online Customer Confirmation Form using the link below within 3 business days of receiving this notice. Replying promptly will confirm your receipt of the notification and prevent you from receiving repeat notices. o www.novasyte.com/hologic/sertera-2023 " Hologic has partnered with IQVIA to conduct follow-up communications should no response be received to this letter. . If you have any questions, please do not hesitate to reach out to Technical Support at BreastHealth.Support@hologic.com