Recall Z-0655-2017 ยท HHM Sound, Uterine
Hologic, Inc
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
| Date | Nov 22, 2016 (initiated Oct 28, 2016) |
| Status | Terminated |
| Reason | Breach in sterile barrier compromising product sterility |
| Root cause | 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 | 600 units (US) ; 24 units (OUS) |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.