Recall Z-1170-2025
Hologic, Inc · initiated January 15, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Codes / lots: Model No- Sertera-14; UDI- 15420045504066; Lot Numbers: E23B23RL, E23B23RM, E23C07RD, E23C07RF, E23C31RC, E23D12RT, E23D12RU, E23D27RW, E23E03RJ, E23E12RT, E23E12RU, E23E29RL, E23E30RM, E23F02RG, E23F07RL, E23F07RM, E23F27R, E23F29RL, E23F29RM, E23F29RN, E23G12RK, E23G25R, E23G31RL, E23H02R, E23H02RA, E23H02RB, E23H28RA, E23H31RF, E23H31RG, E23K02RL, E23K10R, E23K10RA, E23K10RB, E23K31RU, E23L06RK, E23L10RB, E23L22RV, E23L28RB, E23L28RD, E23M21RV, E24A08RL, E24A08RM, E24A26RD, E24B01RF, E24B07RK, E24B22RC, E24B28R, E24B28RA, E24C07RA, E24C21R, E24D26RF, E24E02RD, E24E15RA, E24E22R, E24E22RA, E24E24RB.
Reason for recall
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
FDA-determined cause: Process control
Action taken
On January 15, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Our goal is to create as little disruption to your practice as possible. Below outlines the next steps for customers with affected product(s): " Please quarantine any product(s) from the impacted lots you currently have in your inventory. Impacted lots can be returned through IQVIA as part of the voluntary recall. Please note that you will be issued a credit on your account for the affected product(s). " Refer to the Customer Response Form Instructions to identify your product inventory that is subject to this action. " Confirm receipt of this communication by completing the online Customer Response Form. Please complete and submit the online Customer Response Form even if you no longer have the affected product in inventory. Hologic has partnered with IQVIA to conduct follow up communications should no response be received to this letter. " Hologic will issue a Return Goods Authorization upon receipt of the Customer Response Form and the return of all affected products to Hologic. " If you wish to reorder product, please place a new order via your preferred procurement method. We value your business and thank you for your cooperation. If you have any questions about this communication, please contact BreastHealth.Support@hologic.com or 1-877-371-4372.
Details
- Recall number
- Z-1170-2025
- Initiated
- January 15, 2025
- Posted by FDA
- February 13, 2025
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 55,335 units
- Distribution
- Domestic: Nationwide Distribution
- Recalling firm
- Hologic, Inc, Marlborough, MA