No image published for this recall

No image published for this recall

Infusomat® space pump iv set with anti-siphon valve

Official notice

17 Nov 2023

Last checked

17 Nov 2023

Medium riskHealth Canada

An official Health Canada notice concerns Infusomat® space pump iv set with anti-siphon valve. 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 23, 2023 Published 2023-11-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74606

Official notice

2023-11-17

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 23, 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

74606

Lots

range

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Affected products

Product 1

Affected products - Infusomat® Space Pump Y-Type Blood IV Set With Anti-Siphon Valve, Lot or serial number - lot numbers lower than 0061902124, Model or catalog number - 363419

Product 2

Affected products - Infusomat® Space Pump Low Adsorption IV Set With Anti-Siphon Valve, Lot or serial number - lot numbers lower than 0061902124, Model or catalog number - 363902

Product 3

Affected products - Infusomat® Space Pump Burette IV Set With Anti-Siphon Valve, Lot or serial number - lot numbers lower than 0061902124, Model or catalog number - 363032 363422

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 23, 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® Space Pump Iv Set With Anti-siphon Valve.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74606

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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