SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Reported: September 14, 2016 Initiated: August 2, 2016 #Z-2765-2016
Product Description
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
Reason for Recall
Tip Breakage at the glue joint between the obturator body and tip
Details
- Recalling Firm
- Hologic, Inc
- Units Affected
- 1440 units
- Distribution
- US Nationwide Distribution
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece). Recalled by Hologic, Inc. Units affected: 1440 units.
Why was this product recalled? ▼
Tip Breakage at the glue joint between the obturator body and tip
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2016. Severity: Moderate. Recall number: Z-2765-2016.
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