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Terumo Destination Renal Guiding Sheath (2015-11-06)
- Starting date:
- November 6, 2015
- 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-55940
Affected Products
Terumo Destination Renal Guiding Sheath
Reason
The distal end of certain lots of Terumo Medical Destination products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
Affected products
Terumo Destination Renal Guiding Sheath
Lot or serial number
Lot # RP03
Model or catalog number
RSR01
Companies
- Manufacturer
-
Terumo Medical Corporation
950 Elkton Blvd
Elkton
21921
Maryland
UNITED STATES