Various Catheter and Stent Sets from Cook's Inc (2019-01-07)
- Starting date:
- January 7, 2019
- Posting date:
- January 23, 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-68898
Affected products
- Urethral Dilator Set
- Angled Tip Ureteral Catheter Set
- Bentson Wire Guide
- C-Flex Double Pigtail Ureteral Stent Set
- Sof-Flex Double Pigtail Ureteral Stent Set
- Sof-Flex Multi-Length Ureteral Stent Set
- Urethral Dilation Balloon Catheter with Open Tip
- Universa Soft Ureteral Stent Set
- Universa Firm Ureteral Stent Set
Reason
These products are being recalled because Cook has identified that the affected lots may contain a wire guide that was incorrectly loaded into the wire guide holder. This could lead to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Affected products
A. Urethral Dilator Set
Lot or serial number
8404945
Model or catalog number
073701
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES
B. Angled Tip Ureteral Catheter Set
Lot or serial number
8409525
Model or catalog number
023105
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES
C. Bentson PTFE Wire Guide
Lot or serial number
7760235
7875295
7881599
8062433
8065992
8287799
8290383
8290384
8404559
8404562
8548813
Model or catalog number
638453
635413
638497
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES
D. C-Flex Double Pigtail Ureteral Stent Set
Lot or serial number
- NS7953136
- NS8180860
Model or catalog number
- 036510
- 036516
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES
E. Sof-Flex Double Pigtail Ureteral Stent Set
Lot or serial number
- 8070691
- 8183342
- 8183343
- 8070693
- 8172134
- 8187189
- 8424304
- 7990842
- 7990841
Model or catalog number
- 039512
- 039516
- 039610
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES
F. Sof-Flex Multi-Length Ureteral Stent Set
Lot or serial number
- NS8037667
- 8599605
Model or catalog number
039XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES
G. Urethral Dilation Balloon Catheter with Open Tip
Lot or serial number
8683459
Model or catalog number
UDBS-070029-OW
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES
H. Universa Soft Ureteral Stent Set
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- US-XX
- USH-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES
I. Universa Firm Ureteral Stent Set
Lot or serial number
- 8070702
- 8594594
- NS8197934
- NS8417599
- NS8417600
Model or catalog number
UFH-XXX
Companies
- Manufacturer
-
Cook, Inc.
750 Daniels Way
Bloomington, Indiana
47404
UNITED STATES