Date Initiated by Firm | August 22, 2016 |
Date Posted | September 21, 2016 |
Recall Status1 |
Terminated 3 on February 03, 2017 |
Recall Number | Z-2869-2016 |
Recall Event ID |
74989 |
510(K)Number | K150169 |
Product Classification |
Instrument, biopsy - Product Code KNW
|
Product | Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. |
Code Information |
Lot number: 15C10RA. |
Recalling Firm/ Manufacturer |
Hologic, Inc 250 Campus Dr Marlborough MA 01752-3020
|
For Additional Information Contact | SAME 508-263-8920 |
Manufacturer Reason for Recall | Incorrect label on the Sertera Biopsy Kit |
FDA Determined Cause 2 | Labeling Change Control |
Action | 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 ). |
Quantity in Commerce | 570 units |
Distribution | Nationwide. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KNW
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