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Sarns Cannulae and Tenderflow Pediatric Venous Return Catheters (2014-07-25)
- Starting date:
- July 25, 2014
- Posting date:
- August 8, 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-40857
Recalled products
- Sarns Wire-Reinforced Venous Return Catheter
- Sarns Two-Stage Venous Return Catheter
- Sarns Malleable Venous Return Catheter
- Sarns Soft Flow Extended Aortic Cannula
- Sarns Soft Flow Extended Aortic Cannula
- Sarns Soft Flow Aortic Cannula, Angled Tip
- Tenderflow Pediatric Venous Return Catheters
- Dual Stage Venous Return Catheters
- Sarns Dual-Stage Malleable Venous Return Catheter
Reason
During an inspection of finished product, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded specification for the finished Sarns and Terumo cannulae. Terumo CVS has not received any reports of loose particulate during clinical use. Terumo CVS has decided to remove all affected lots that were distributed.
Affected products
A. Sarns Wire-Reinforced Venous Return Catheter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 14036
- 9453
- 9465
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES
B. Sarns Two-Stage Venous Return Catheter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 15949
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES
C. Sarns Malleable Venous Return Catheter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 4881
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES
D. Sarns Soft Flow Extended Aortic Cannula
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 4948
- 4950
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES
E. Sarns Soft Flow Extended Aortic Cannula
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 4949
- 4951
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES
F. Sarns Soft Flow Aortic Cannula, Angled Tip
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 5761
- 5762
- 5767
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES
G. Tenderflow Pediatric Venous Return Catheters
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 813544
- 813546
- 813547
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES
H. Dual Stage Venous Return Catheters
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 813583
- 813586
- 813588
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES
I. Sarns Dual-Stage Malleable Venous Return Catheter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 4936
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES