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Cook 9 FR. Evolution Rl Dilator Sheath Set (2014-02-24)
- Starting date:
- February 24, 2014
- Posting date:
- March 25, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38587
Recalled Products
Cook 9 FR. Evolution Rl Dilator Sheath Set
Reason
Label placed on the handle of the device indicates it is 11 FR. In diameter when in fact it is 9 FR. All packaging and other labeling indicates the correct sizing information. One lot number is being recalled in Canada.
Affected products
Cook 9 FR. Evolution Rl Dilator Sheath Set
Lot or serial number
LR-EVN-9.0-RL
Model or catalog number
N116626
Companies
- Manufacturer
-
Cook Vascular Inc. CVI
1186 Montgomery Lane
Vandergrift
15690
Pennsylvania
UNITED STATES