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Medfusion® syringe infusion pumps

Official notice

18 Jan 2024

Last checked

18 Jan 2024

Critical riskHealth Canada

An official Health Canada notice concerns Medfusion® syringe infusion pumps. Smiths Medical identified that certain barrel clamp guides may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded. The affected barrel clamp guide part (mechanism) number is G6000716 and the associated affected lot numbers are P0407365, P0486670 and P0561740. The listed Medfusion® syringe infusion pumps, contain the barrel clamp guide mechanism. Recall start date: December 28, 2023 Published 2024-01-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74928

Official notice

2024-01-18

The hazard

Smiths Medical identified that certain barrel clamp guides may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded. The affected barrel clamp guide part (mechanism) number is G6000716 and the associated affected lot numbers are P0407365, P0486670 and P0561740. The listed Medfusion® syringe infusion pumps, contain the barrel clamp guide mechanism. Recall start date: December 28, 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

74928

Lots

are

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Affected products

Product 1

Affected products - Medfusion® Syringe Infusion Pumps, Lot or serial number - Contact the manufacturer., Model or catalog number - 3500 3500-415 3500-500

Product 2

Affected products - Medfusion® Model 4000 Syringe Infusion Pump, Lot or serial number - Contact the manufacturer., Model or catalog number - 4000-0105-51 4000-0106-01 4000-0101-51

Risk / hazard

Smiths Medical identified that certain barrel clamp guides may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded. The affected barrel clamp guide part (mechanism) number is G6000716 and the associated affected lot numbers are P0407365, P0486670 and P0561740. The listed Medfusion® syringe infusion pumps, contain the barrel clamp guide mechanism. Recall start date: December 28, 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, Medfusion® Syringe Infusion Pumps.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

74928

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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