EQUISTREAM Split Tip Catheter, Straight Standard Kit, Split Tip Alphacurve Pre-Curved Catherer, Standard Kit, Split Tip Catheter, Straight, MI Kit, GLIDEPATH Long Term Hemodialysis Catheter with Preloaded Stylet, Straight, Standard Kit and Exchange K...
- Starting date:
- May 24, 2019
- Posting date:
- June 14, 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-70211
Last updated: 2019-06-14
Affected Products
A. EQUISTREAM Split Tip Catheter, Straight, Standard Kit
B. EQUISTREAM Split Tip Catheter, Alphacurve Pre-Curved Catheter, Standard Kit
C. EQUISTREAM Split Tip Catheter, Straight, MI Kit
D. GLIDEPATH Long Term Hemodialysis Catheter with Preloaded Stylet, Straight, Standard Kit
E. GLIDEPATH Long Term Hemodialysis Catheter with Preloaded Stylet, Straight, Exchange Kit
Reason
It has been identified that selected product code/lot number combinations of the EQUISTREAM and GLIDEPATH Long-Term Hemodialysis Catheters may be at risk of containing a tunneler with a plastic barb tip that is susceptible to breaking. The purpose of the barb tip is to attach to the catheter and create a connection, which allows the catheter to be threaded through the tissue as the tunnel is created.
Affected products
A. EQUISTREAM Split Tip Catheter, Straight, Standard Kit
Lot or serial number
RECW0585
RECW0913
REDN2376
Model or catalog number
5903190
5903270
5903310
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
B. EQUISTREAM Split Tip Catheter, Alphacurve Pre-Curved Catheter, Standard Kit
Lot or serial number
RECX3120
Model or catalog number
5905240
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
C. EQUISTREAM Split Tip Catheter, Straight, MI Kit
Lot or serial number
RECZ3014
Model or catalog number
5904270
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
D. GLIDEPATH Long Term Hemodialysis Catheter with Preloaded Stylet, Straight, Standard Kit
Lot or serial number
RECX0998
RECX1122
RECX2895
RECZ0639
Model or catalog number
5393230
5393270
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES
E. GLIDEPATH Long Term Hemodialysis Catheter with Preloaded Stylet, Straight, Exchange Kit
Lot or serial number
RECX0642
RECX1119
RECX2707
RECZ0753
RECZ1125
REDN1398
Model or catalog number
5397190
5397230
5397270
5397310
5397350
Companies
- Manufacturer
-
Bard Access Systems Inc.
605 North 5600 West
Salt Lake City
84116
Utah
UNITED STATES