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Cook Bush Ureteral Illuminating Catheter Set
- Starting date:
- March 7, 2017
- Posting date:
- April 4, 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-62894
Reason
The proximal black component that connects to the distal transparent component of the catheter may overheat and melt. There have been no reports of overheating along the transparent component of the catheter, which is the part of the device that comes into contact with the patient's urethra, bladder, and ureter. Potential adverse events that may occur if these devices overheat and come into direct contact with skin include burns to the skin.
Affected products
Cook Bush Ureteral Illuminating Catheter Set
Lot or serial number
More than 10, contact manufacturer
Model or catalog number
084120
084510
J-BICS-058020
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington
47404
Indiana
UNITED STATES