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Transfer set (minicap extended life pd transfer set with twist clamp – extra long)

Official notice

1 Nov 2024

Last checked

1 Nov 2024

Medium riskHealth Canada

An official Health Canada notice concerns Transfer set (minicap extended life pd transfer set with twist clamp – extra long). Baxter Healthcare Corporation (Baxter) is issuing an urgent medical device correction for the Minicap Extended Life Pd Transfer Sets listed, which are manufactured with peroxide-cured silicone tubing that transfers solution to and from the patient. Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to nondioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. The source of the NDL PCBAs and/or NDL PCBs in those recalls was due to the manufacturing process of the silicone tubing. Recall Start Date: October 21, 2024 Published 2024-11-01.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76427

Official notice

2024-11-01

The hazard

Baxter Healthcare Corporation (Baxter) is issuing an urgent medical device correction for the Minicap Extended Life Pd Transfer Sets listed, which are manufactured with peroxide-cured silicone tubing that transfers solution to and from the patient. Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to nondioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. The source of the NDL PCBAs and/or NDL PCBs in those recalls was due to the manufacturing process of the silicone tubing. Recall Start Date: October 21, 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

76427

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Affected products

Product 1

Affected products - Transfer Set (Minicap Extended Life Pd Transfer Set With Twist Clamp – Extra Long), Lot or serial number - Lot H20B11116 and higher, Model or catalog number - R5C4484

Risk / hazard

Baxter Healthcare Corporation (Baxter) is issuing an urgent medical device correction for the Minicap Extended Life Pd Transfer Sets listed, which are manufactured with peroxide-cured silicone tubing that transfers solution to and from the patient. Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to nondioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. The source of the NDL PCBAs and/or NDL PCBs in those recalls was due to the manufacturing process of the silicone tubing. Recall Start Date: October 21, 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: Baxter Healthcare, Transfer Set.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76427

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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