Hologic, Inc recalls SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization S…

Recall date

August 2, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2766-2016

FDA classification

Class II

Brand / firm

Hologic, Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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