Recall Z-2766-2016— Hologic, Inc
Class II · Terminated
Class II FDA medical device recall by Hologic, Inc, initiated 2016-08-02, terminated 2017-03-30. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Tip Breakage at the glue joint between the obturator body and tip.
- Recalling firm
- Hologic, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-02
- Terminated
- 2017-03-30
- Firm location
- Marlborough, MA, United States
Product description
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
Reason for recall
Tip Breakage at the glue joint between the obturator body and tip
Data sourced from openFDA. This site is unofficial and independent of the FDA.