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Olympus distal attachment and disposable emr kit

Official notice

31 Aug 2023

Last checked

31 Aug 2023

Medium riskHealth Canada

An official Health Canada notice concerns Olympus distal attachment and disposable emr kit. Devices contain di-2-ethylhexyl phthalate (DEHP). Olympus has previously announced on the labeling that the product contains DEHP. Since Olympus has confirmed that alternative products can be provided, Olympus has decided to ask customers to cease using the subject products and to further remove them. In general, potential patient harms associated with the use of plastic products containing DEHP include: chemical exposure, hypersensitivity/allergic reaction, endocrine disruption, reproductive and developmental toxicity and carcinogenicity. Long term DEHP toxicity may occur if a distal attachment inadvertently becomes a retained foreign body with resultant leaching over time. Olympus has not received any reports of these harms occurring from the use of our products. Recall start date: August 17, 2023 Published 2023-08-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74217

Official notice

2023-08-31

The hazard

Devices contain di-2-ethylhexyl phthalate (DEHP). Olympus has previously announced on the labeling that the product contains DEHP. Since Olympus has confirmed that alternative products can be provided, Olympus has decided to ask customers to cease using the subject products and to further remove them. In general, potential patient harms associated with the use of plastic products containing DEHP include: chemical exposure, hypersensitivity/allergic reaction, endocrine disruption, reproductive and developmental toxicity and carcinogenicity. Long term DEHP toxicity may occur if a distal attachment inadvertently becomes a retained foreign body with resultant leaching over time. Olympus has not received any reports of these harms occurring from the use of our products. Recall start date: August 17, 2023

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

74217

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Affected products

Product 1

Affected products - Disposable Emr Kit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - K-011 K-001 K-002 K-012 K-003 K-004

Risk / hazard

Devices contain di-2-ethylhexyl phthalate (DEHP). Olympus has previously announced on the labeling that the product contains DEHP. Since Olympus has confirmed that alternative products can be provided, Olympus has decided to ask customers to cease using the subject products and to further remove them. In general, potential patient harms associated with the use of plastic products containing DEHP include: chemical exposure, hypersensitivity/allergic reaction, endocrine disruption, reproductive and developmental toxicity and carcinogenicity. Long term DEHP toxicity may occur if a distal attachment inadvertently becomes a retained foreign body with resultant leaching over time. Olympus has not received any reports of these harms occurring from the use of our products. Recall start date: August 17, 2023

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: Olympus Medical, Olympus Distal Attachment And Disposable Emr Kit.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74217

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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