Sertera 14 Gauge Biopsy Device-intended to obtain recall
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Why was Sertera 14 Gauge Biopsy Device-intended to obtain recalled?
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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: 15420045504066 Lot Number: E22H19RM
- Product
- Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
- Recalling firm
- Hologic, Inc
- Quantity
- 756 units
- Distribution
- US Nationwide distribution.
- Recall date
- July 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)