Type II Recall - Various Catheter and Stent Sets from Cook's Inc

January 23, 2019
Health Canada Drug Alerts


Affected products

  1. Urethral Dilator Set
  2. Angled Tip Ureteral Catheter Set
  3. Bentson Wire Guide
  4. C-Flex Double Pigtail Ureteral Stent Set
  5. Sof-Flex Double Pigtail Ureteral Stent Set
  6. Sof-Flex Multi-Length Ureteral Stent Set
  7. Urethral Dilation Balloon Catheter with Open Tip
  8. Universa Soft Ureteral Stent Set
  9. 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


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