U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Sound, uterine - Product Code HHM
원인
Breach in sterile barrier compromising product sterility.
조치
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.
Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
제품 설명
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. || SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. || For uterine sound