Health product recall

Catheter Extension

Last updated

Summary

Product
Catheter Extension
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Catheter Extension

More than 10 numbers, contact manufacturer.

2843241
2843181
2843191

Issue

The manufacturer determined through testing that non-dioxin-like polychlorinated biphenyl acids (PCBAs) could leach from the stay•safe catheter extension, which are manufactured using peroxide cross-linked silicone tubing. Please note that PCBAs are chemically different from polychlorinated biphenyls (PCBs), which were not identified. To date, no complaints have been received related to PCBAs. PCBA levels decrease with shorter stay•safe catheter extension and decrease over the treatment time.

Recall start date: February 20, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Fresenius Medical Care Ag
Else-Kroner-Strasse 1, Bad Homburg, Germany, 61352
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75309

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