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Mobicath Bi-Directional Guiding Sheath
- Starting date:
- November 16, 2012
- Posting date:
- December 10, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-16281
Recalled Products
A. Mobicath Bi-Directional Guiding Sheath
Reason
The manufacturer has observed some anomalies of the inner lumen of these products with the implementation of a new inspection tool during visual inspection. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).
Affected products
A. Mobicath Bi-Directional Guiding Sheath
Lot or serial number
W2172712, W2190464, W2196349, W2196351, W2211853
Model or catalog number
D-1400-10, D-1400-11
Companies
- Manufacturer
- Greatbatch Medical