Recall Z-2766-2016

Hologic, Inc · initiated August 2, 2016

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator

Codes / lots: Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.

Reason for recall

Tip Breakage at the glue joint between the obturator body and tip

FDA-determined 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.

Details

Recall number: Z-2766-2016
Initiated: August 2, 2016
Posted by FDA: September 8, 2016
Terminated: March 30, 2017
Product code: GDF – Guide, Needle, Surgical
Quantity: 535 units
Distribution: US Nationwide Distribution
Recalling firm: Hologic, Inc, Marlborough, MA

Official FDA recall record

Other products in the same recall event

Recall	Product	Initiated
Z-2765-2016 Class II	SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.…Tip Breakage at the glue joint between the obturator body and tip	08/02/2016Terminated