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Smiths medical rotators

Official notice

1 Dec 2023

Last checked

1 Dec 2023

Medium riskHealth Canada

An official Health Canada notice concerns Smiths medical rotators. Smiths Medical has identified a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the device's o-ring may be oversized affecting seal integrity. Recall Start Date: November 9, 2023 Published 2023-12-01.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74658

Official notice

2023-12-01

The hazard

Smiths Medical has identified a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the device's o-ring may be oversized affecting seal integrity. Recall Start Date: November 9, 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

74658

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Affected products

Product 1

Affected products - Rotating Adaptors, Lot or serial number - 4330826 4384397, Model or catalog number - MX497HP

Product 2

Affected products - 700PSI Stopcock W/ Rotator, Lot or serial number - 4355397 4380735 4387234, Model or catalog number - MX433-1R

Product 3

Affected products - 48in (121.9cm) Injection Line Rotating Adapt (900PSI), Lot or serial number - 4404698 4371082 4398429 4383431 4387987, Model or catalog number - MX694R

Product 4

Affected products - Pressure Transducers, Lot or serial number - 4387983 4383385 4392487, Model or catalog number - MX20449 M20178R2

Risk / hazard

Smiths Medical has identified a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the device's o-ring may be oversized affecting seal integrity. Recall Start Date: November 9, 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: Smiths Medical Asd, Smiths Medical Rotators.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74658

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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