Introducer Sheath (2020-09-08)
- Starting date:
- September 8, 2020
- Posting date:
- October 2, 2020
- 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-74065
Last updated:
2020-10-01
Affected Products
- H.Lee Safesheath CSG (Coronary Sinus Guide) Hemostatic Introducer System
- Preclude SNAP Spittable Sheath Introducer
- Worley Advanced LVI Lateral Vein Introducer Kit
Reason
The recall reason is a manufacturing defect which may prevent the splittable foam washer within the sheath hub from completely peeling apart with the rest of Introducer Sheath.
Affected products
-
H.Lee Safesheath CSG (Coronary Sinus Guide) Hemostatic Introducer System
Lot or serial number
- I1825799
- I1825806
- I1838620
- I1845505
Model or catalog number
- WOR-CSG-B1-09
- WOR-CSG-B2-09
- WOR-CSG-BL1-09
Companies
- Manufacturer
-
Merit Medical Systems Inc.
1600 West Merit Parkway
South Jordan
84095
Alabama
UNITED STATES
B. Preclude SNAP Spittable Sheath Introducer
Lot or serial number
I1866067
Model or catalog number
PLS-2507
Companies
- Manufacturer
-
Merit Medical Systems Inc.
1600 West Merit Parkway
South Jordan
84095
Alabama
UNITED STATES
C. Worley Advanced LVI Lateral Vein Introducer Kit
Lot or serial number
I1825782
Model or catalog number
WORLVI-75-5-62-55-RE
Companies
- Manufacturer
-
Merit Medical Systems Inc.
1600 West Merit Parkway
South Jordan
84095
Alabama
UNITED STATES