SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound
This recall has been terminated (originally issued November 22, 2016).
- Company
- Hologic, Inc
- Recall Initiated
- October 28, 2016
- Posted
- November 22, 2016
- Terminated
- August 18, 2017
- Recall Number
- Z-0655-2017
- Quantity
- 600 units (US) ; 24 units (OUS)
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Breach in sterile barrier compromising product sterility
Distribution
Worldwide Distribution - US (Nationwide) and Internationally to Finland and Austria.
Lot / Code Info
Lot Code US: 16E25RC 16E25RD 16F16R Lot Code OUS: 16E25RB
Root Cause
Package design/selection
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.