Duo Flow Double Lumen and Soft-Line Catheter Sets, Raulerson Pre-Curved Duo-Flow IJ Catgeter With Soft Tip (2018-07-13)
- Starting date:
- July 13, 2018
- Posting date:
- July 27, 2018
- 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-67318
Affected products
A. Duo Flow Double Lumen Catheter Sets
B. Raulerson Pre-Curved Duo-Flow IJ Catgeter With Soft Tip
C. Soft-Line Catheter Sets
Reason
A recall has been initiated for various products in the short term hemodialysis line due to the potential for the suture wings to crack or break. No patient injury has been reported. Implanted catheters with intact suture wings do not need to be removed. However, an alternative method of catheter securement should be initiated for all implanted catheters. Potential patient injury includes catheter dislocation, bleeding and air emboli.
Affected products
A. Duo Flow Double Lumen Catheter Sets
Lot or serial number
MCBF000
MCBG700
MCDP270
MCFF150
MCFF580
MCFF780
MKAH230
MKAH580
Model or catalog number
XTP114MT
XTP94MT
XTP96MT
Companies
- Manufacturer
-
Medical Components Inc,
Also trading as Medcomp
1499 Delp Drive
Harleysville
19438
Pennsylvania
UNITED STATES
B. Raulerson Pre-Curved Duo-Flow IJ Catgeter With Soft Tip
Lot or serial number
MCDT880
Model or catalog number
XTP94IJS
Companies
- Manufacturer
-
Medical Components Inc,
Also trading as Medcomp
1499 Delp Drive
Harleysville
19438
Pennsylvania
UNITED STATES
C. Soft-Line Catheter Sets
Lot or serial number
MCBM870
MHTH950
MJKN210
MJLP090
MKAM870
MLBA570
MLBK460
MSHN190
Model or catalog number
T116M
T94M
T96M
Companies
- Manufacturer
-
Medical Components Inc,
Also trading as Medcomp
1499 Delp Drive
Harleysville
19438
Pennsylvania
UNITED STATES