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Catheter extension

Official notice

28 Mar 2024

Last checked

28 Mar 2024

Medium riskHealth Canada

An official Health Canada notice concerns Catheter extension. 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 Published 2024-03-28.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75309

Official notice

2024-03-28

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

75309

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Affected products

Product 1

Affected products - Catheter Extension, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 2843241 2843181 2843191

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Fresenius Medical Care, Catheter Extension.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75309

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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