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SureSight Obturator - Introducer Localization System
- Starting date:
- July 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60062
Affected Products
SureSight Obturator - Introducer Localization System
Reason
THERE HAVE BEEN REPORTS THAT THE LOCALIZING OBTURATOR IS BREAKING BEFORE AND DURING PROCEDURES AT THE GLUE JOINT BETWEEN THE BODY AND THE TIP. THESE BREAKAGES IN THE FIELD MAY RESULT IN HARM TO THE PATIENT AND THE NEED FOR ADDITIONAL INTERVENTION TO REMOVE THE BROKEN PRODUCT FROM THE PATIENT.
Affected products
SureSight Obturator - Introducer Localization System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ILS-0914-12-OB
ILS-0914-20-OB
Companies
- Manufacturer
-
Hologic, Inc.
250 Campus Drive
Marlborough
01752
Massachusetts
UNITED STATES