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Renew Reusable Scissor, Grasper And Dissector Tips
- Starting date:
- July 14, 2017
- Posting date:
- August 15, 2017
- 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-64216
Reason
Microline Surgical, inc., has initiated this global voluntary recall which applies to all renew reusable tips (scissors, graspers, and dissectors). This recall is due to a malfunction related to the heat shrink insulation tube that is located immediately proximal to the metal tip. Microline Surgical, has received customer reports that the heat-shrink insulation tube may split during autoclave (sterilization/re-sterilization), and could fall-off during surgery, and if cautery is used, there is potential for burn.
Affected products
Renew Reusable Scissor, Grasper And Dissector Tips
Lot or serial number
All lots
Model or catalog number
3111
3121
3141
3151
3161
Companies
- Manufacturer
-
Microline Surgical, Inc.
50 DUNHAM ROAD, SUITE 1500
Beverly
01915
Massachusetts
UNITED STATES