MAHURKAR PC Kit, Qplus SE Kits, Acute High Pressure Triple Lumen Catheter Kit Curved and Straight Extensions, Acute Dual Lumen Catheter Kit Pre-Curved, Acute Dual Lumen Catheter Kits (2019-04-24)
- Starting date:
- April 24, 2019
- Posting date:
- June 7, 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-70103
Last updated: 2019-06-07
Affected Products
- MAHURKAR PC Kit
- MAHURKAR QPlus SE Kits
- MAHURKAR Acute High Pressure Triple Lumen Catheter Kit Curved Extensions
- MAHURKAR Acute High Pressure Triple Lumen Catheter Kit Straight Extensions
- MAHURKAR Acute Dual Lumen Catheter Kit Pre-Curved
- MAHURKAR Acute Dual Lumen Catheter
- MAHURKAR Acute Dual Lumen Catheter Kits
Reason
In some instances, priming volumes for the MAHURKAR and Argyle acute catheters were established using the maximum calculated volume plus an additional volume to ensure the catheter was fully locked. This approach was chosen to ensure that the lumen is always fully primed, minimizing risk of catheter thrombosis. Therefore, the printed priming volumes on current MAHURKAR And Argyle acute catheters and IFUs exceed the actual locking volume needed to fully fill each lumen. Depending on the catheter size and configuration, a variation from 0.1 mL - 0.5 mL per lumen from the printed priming value (actual locking volume would be lower) could be observed.
Affected products
A. MAHURKAR PC Kit
Lot or serial number
All lots.
Model or catalog number
8888115132
8888115162
8888115192
8888115242
8888135133
8888135163
8888135193
8888135243
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
B. MAHURKAR QPlus SE Kits
Lot or serial number
All lots.
Model or catalog number
8888135131
8888135161
8888135191
8888135241
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
C. MAHURKAR Acute High Pressure Triple Lumen Catheter Kit Curved Extensions
Lot or serial number
All lots.
Model or catalog number
8888345603HP
8888345611HP
8888345629HP
8888345637HP
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
D. MAHURKAR Acute High Pressure Triple Lumen Catheter Kit Straight Extensions
Lot or serial number
All lots.
Model or catalog number
8888340629HP
8888340637HP
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
E. MAHURKAR Acute Dual Lumen Catheter Kit Pre-Curved
Lot or serial number
All lots.
Model or catalog number
8888115132
8888115162
8888115192
8888115242
8888135133
8888135163
8888135193
8888135243
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
F. MAHURKAR Acute Dual Lumen Catheter
Lot or serial number
All lots.
Model or catalog number
8813-816009
8813794005
8813794009
8813816005
8817-142005
8817145005
8830-414001
8830414002
8831-662001
8832-539001
8832-539002
8832-539003
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
G. MAHURKAR Acute Dual Lumen Catheter Kits
Lot or serial number
All lots.
Model or catalog number
8813-793009
8813-793013
8813-817005
8813-817009
8817-143005
8817146001
8817146007
8817149007
8830-415001
8830-415003
8831-173011
8831173010
8831661001
8832539006
8832539007
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES