Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Recall
- Recall Number
- Z-2035-2023
- Event Number
- 92357
- Firm
- Hologic, Inc
- FEI Number
- 1000120743
- Product Code
- KNW
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- May 2, 2023
- Posted
- June 29, 2023
- Address
- 250 Campus Dr, Marlborough, MA, 01752-3020
Description
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
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 [email protected]
US Nationwide distribution.
756 units