Recall Z-2869-2016
Hologic, Inc · initiated August 22, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Codes / lots: Lot number: 15C10RA.
Reason for recall
Incorrect label on the Sertera Biopsy Kit
FDA-determined cause: Labeling Change Control
Action taken
Hologic notified customers in the United States through Certified letter on 8/22/16. The letter contains instructions of returning the product, provides contact information, and includes a postage-paid return card for the consignee to complete and return to Hologic. Contact technical support at 508-263-2900 or l-800-442:9892 Press Option 6 ).
Details
- Recall number
- Z-2869-2016
- Initiated
- August 22, 2016
- Posted by FDA
- September 21, 2016
- Terminated
- February 3, 2017
- Product code
- KNW – Instrument, Biopsy
- Quantity
- 570 units
- Distribution
- Nationwide.
- Recalling firm
- Hologic, Inc, Marlborough, MA