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Infusomat® administration sets

Official notice

7 Nov 2023

Last checked

7 Nov 2023

Medium riskHealth Canada

An official Health Canada notice concerns Infusomat® administration sets. In the identified lot number range of administration sets, the tubing outer diameter may vary in size. Additionally, the length of the tubing which contacts the air sensor may be too short resulting in the need to stretch the tubing to properly fit within the Infusomat space pump. If the tubing is stretched or the tubing outer diameter is too small, this may result in suboptimal coupling between the administration set and the air-in-line sensor dampening the signal of the air-in-line sensor. If the signal is dampened, the Infusomat space pump may generate false air-in-line alarms. Recall start date: October 24, 2023 Published 2023-11-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74553

Official notice

2023-11-07

The hazard

In the identified lot number range of administration sets, the tubing outer diameter may vary in size. Additionally, the length of the tubing which contacts the air sensor may be too short resulting in the need to stretch the tubing to properly fit within the Infusomat space pump. If the tubing is stretched or the tubing outer diameter is too small, this may result in suboptimal coupling between the administration set and the air-in-line sensor dampening the signal of the air-in-line sensor. If the signal is dampened, the Infusomat space pump may generate false air-in-line alarms. Recall start date: October 24, 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

74553

Lots

range

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Affected products

Product 1

Affected products - Infusomat® Administration Sets, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 362033 362035 362050 362432 362911 363032 363410 363419 363420 363421 363422 363423 363424 363430 363433 363901 363902 363904 470119 490037 490038 490100 490101 490102 490103 490104 490105

Risk / hazard

In the identified lot number range of administration sets, the tubing outer diameter may vary in size. Additionally, the length of the tubing which contacts the air sensor may be too short resulting in the need to stretch the tubing to properly fit within the Infusomat space pump. If the tubing is stretched or the tubing outer diameter is too small, this may result in suboptimal coupling between the administration set and the air-in-line sensor dampening the signal of the air-in-line sensor. If the signal is dampened, the Infusomat space pump may generate false air-in-line alarms. Recall start date: October 24, 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: B Braun Medical, Infusomat® Administration Sets.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74553

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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