SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) co
FDA device recall Z-0655-2017 · posted 2016-11-22 · Terminated
Recall details
- Recalling firm
- Hologic, Inc
- Reason for recall
- Breach in sterile barrier compromising product sterility
- Action taken
- 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
- Status
- Terminated
- Product code
- HHM
- Quantity affected
- 600 units (US) ; 24 units (OUS)
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
- Date initiated
- 2016-10-28
- Date posted
- 2016-11-22
- Date terminated
- 2017-08-18
- Location
- Marlborough, MA
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