Catheter Extension
Brand(s)
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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