FDAFDA · Food and drugs·Recall number Z-2766-2016
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
Published September 14, 2016 · Recall initiated: August 2, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Tip Breakage at the glue joint between the obturator body and tip
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hologic, Inc
- Distributor
- US Nationwide Distribution
- Lot
- Lot Codes: 512501, 512502, 512504, 512588, 601501, 601535, 601536, 601587, 602501, 602502, 602503, 602504, 603522, 604557, 604558, 604591, 605501, 605502, 605543, 605547.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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