SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
- Company
- Hologic, Inc
- Recall Initiated
- August 2, 2016
- Posted
- September 8, 2016
- Terminated
- March 30, 2017
- Recall Number
- Z-2765-2016
- Quantity
- 1440 units
- Firm Location
- Marlborough, MA
Reason for Recall
Tip Breakage at the glue joint between the obturator body and tip
Distribution
US Nationwide Distribution
Lot / Code Info
Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.
Root Cause
Process control
Action Taken
Hologic sent an Important Product Recall letter to customers in the United States through Certified letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory and cease use of all affected recalled product. Customers were asked to complete the enclosed Recall Response Card indicating whether you have any of the recalled product on hand, as well as the quantity of product that you have in stock.