CanadaBeacon® Tip Centimeter Sizing Catheter (models N5.0-35-100-P-10S-0-CSC-20, NR5.0-35-70-P-10S-0-CSC-20 and N5.0-35-100-P-10S-PIG-CSC-20); affected lot/serial numbers are listed as “more than 20 numbers” — contact the manufacturer to confirm if yours is affected. The marker bands supplied by an external supplier may crack or break; the issue was identified during production and tensile testing and is isolated to specific supplier lots. Contact the manufacturer for additional information.
What's being recalled
Companies: Cook, Incorporated, 750 Daniels Way, Bloomington, Indiana, United States, 47404.
How to identify it
Affected products: Beacon® Tip Centimeter Sizing Catheter; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: N5.0-35-100-P-10S-0-CSC-20
Affected products: Beacon® Tip Centimeter Sizing Catheter; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: NR5.0-35-70-P-10S-0-CSC-20
Affected products: Beacon® Tip Centimeter Sizing Catheter; Lot or serial number: More than 20 numbers, contact manufacturer.; Model or catalogue number: N5.0-35-100-P-10S-PIG-CSC-20
The hazard
Cook Medical identified that the marker bands on impacted products may be at an increased risk of cracking/breakage. The subject marker bands are provided to Cook by an external supplier. This issue was identified internally during production. Following issue detection, product samples underwent tensile testing, where one sample cracked while being manipulated to load into the test fixture. While there is a quality control check in place to detect this failure mode prior to product release, all tested samples had underwent this quality control check prior to being tested. This is indicative that the subject marker bands may fail at a point past the quality control check. This issue has been isolated to specific supplier lots of these marker bands.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)