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Terminated

SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound

FDA Recall Z-0655-2017 · Posted 2016-11-22

Recalling FirmHologic, Inc
Recall StatusTerminated
Product CodeHHM
Date Initiated2016-10-28
Date Terminated2017-08-18
Product Quantity600 units (US) ; 24 units (OUS)

Reason for Recall

Breach in sterile barrier compromising product sterility

Firm 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.

Root Cause

Package design/selection

Distribution Pattern

Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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