Health product recall

Teflon Coated Bentson and Wireguides

Brand(s)
Last updated

Summary

Product
Teflon Coated Bentson and Wireguides
Issue
Medical devices - Sterility Issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Teflon Coated Bentson

> 50 lot numbers, contact manufacturer.

TSFBP-35-145
TSFB-35-200
TSFB-35-145
TSFB-35-80

Teflon Coated Safe-T-J Wireguides

> 50 lot numbers, contact manufacturer.

THSCF-35-180-1.5-ROSEN
THSCF-35-80-1.5-ROSEN
TSCF-35-145-3
TSCF-35-80-3
TSCF-35-180-3
THSCF-35-145-1.5-ROSEN

Teflon Coated Generic Wireguides

> 50 lot numbers, contact manufacturer.

TDOC-35-145-0-3
THSCF-25-260-3
TSF-35-180
TSF-35-145
TSMB-35-145
TSF-25-145
THSCF-25-180-3
THSCF-35-80-3
TSF-32-145

Roadrunner Pc Wireguide

> 50 lot numbers, contact manufacturer.

RFSPC-35-145
RFPC-35-145
RPC-35-145

Connecting Tubes Pvc

> 50 lot numbers, contact manufacturer.

CTU-14.0-40-ST

Cope Mandril Wireguides

> 50 lot numbers, contact manufacturer.

PMG-18SP-125-COPE
PMG-18SP-60-COPE
PMG-18SP-60-COPE-NT

Issue

Cook Medical identified that devices from the affected device lots may have a breach of the chevron seal of the packaging. therefore, the sterility of affected devices may be compromised.

Recall start date: August 16, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - Radiology
Companies

Cook, Inc.

750 Daniels Way, Bloomington, Indiana, United States, 47404

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64493

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