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U.S. Department of Health and Human Services

Class 2 Device Recall Hologic

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  Class 2 Device Recall Hologic see related information
Date Initiated by Firm October 28, 2016
Date Posted November 22, 2016
Recall Status1 Terminated 3 on August 18, 2017
Recall Number Z-0655-2017
Recall Event ID 75558
Product Classification Sound, uterine - Product Code HHM
Product SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices.
SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices.

For uterine sound
Code Information Lot Code US: 16E25RC 16E25RD 16F16R  Lot Code OUS: 16E25RB
Recalling Firm/
Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Breach in sterile barrier compromising product sterility
FDA Determined
Cause 2
Package design/selection
Action Hologic notified customers in the United States through Certified letter on 10/28/16. The letter contains instructions with the option of returning or destroying the product, provides contact information, and includes a postage paid return card for the consignee to complete and return to Hologic.Questions or require clarification of the response process please contact 1- 800-442-9892 and selection option 6 and then option 2 for surgical product technical support. For questions regarding this recall call 508-263-8920.
Quantity in Commerce 600 units (US) ; 24 units (OUS)
Distribution Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
Total Product Life Cycle TPLC Device Report

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.