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Terminated

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

FDA Recall Z-2766-2016 · Posted 2016-09-08

Recalling FirmHologic, Inc
Recall StatusTerminated
Product CodeGDF
Date Initiated2016-08-02
Date Terminated2017-03-30
Product Quantity535 units

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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