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
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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/ Manufacturer |
Hologic, Inc 250 Campus Dr Marlborough MA 01752-3020
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For Additional Information Contact | SAME 508-263-8920 |
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 |
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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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