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Arrow Edge and Nextstep Antegrade Hemodialysis Catheterization Sets (2014-02-07)
- Starting date:
- February 7, 2014
- Posting date:
- March 20, 2014
- 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-38457
Recalled Products
A. Arrow edge Hemodialysis Catheterization set
B. Nextstep Antegrade Hemodialysis Catheterization set
Reason
The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.
Affected products
A. Arrow edge Hemodialysis Catheterization set
Lot or serial number
CS-15242-I
CS-15282-I
Model or catalog number
RF2060811
RF2071317
Companies
- Manufacturer
-
Arrow International, Inc.
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
B. Nextstep Antegrade Hemodialysis Catheterization set
Lot or serial number
CS-15192-SFX
CS-15232-SFX
CS-15272-SFX
CS-15502-SFX
Model or catalog number
RF2107409
RF2108324
RF2108326
RF2108330
Companies
- Manufacturer
-
Arrow International, Inc.
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES