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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