Synchro 2/ Guidewire (Soft, Standard) (2019-03-04)
- Starting date:
- March 4, 2019
- Posting date:
- March 15, 2019
- 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-69316
Affected Products
- Synchro 2/ Soft Guidewire
- Synchro 2/ Standard Guidewire
Reason
Stryker Neurovascular has become aware that the product labels (pouch and carton) for Synchro 2 products contain an incorrect value in millimeters (0.036 mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014 in) on the label is correct. The correct values are 0.014 in (0.36mm). 0.036 mm represents a typographical error.
Affected products
A. Synchro 2/ Soft Guidewire
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- M00326010
- M00326310
Companies
- Manufacturer
-
Stryker Neurovascular
47900 Bayside Parkway
Fremont
94538
California
UNITED STATES
B. Synchro 2/ Standard Guidewire
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- M00326410
- M00326510
Companies
- Manufacturer
-
Stryker Neurovascular
47900 Bayside Parkway
Fremont
94538
California
UNITED STATES