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Medfusion syringe infusion pumps

Official notice

14 Mar 2024

Last checked

14 Mar 2024

Medium riskHealth Canada

An official Health Canada notice concerns Medfusion syringe infusion pumps. Smiths Medical is issuing this letter to notify customers not to use Cardinal Health branded Monoject syringes with Medfusion 3500 and 4000 Syringe Pumps. On September 20, 2023, Cardinal Health issued a medical device product correction for the Cardinal Health branded Monoject Luer-Lock Tip Syringes due to demonstrated recognition and compatibility issues with syringe infusion pumps due to changes made to the dimensions of the syringes. As a result, Cardinal Health recommends that these syringes not be used on syringe infusion pumps. Recall Start Date: February 29, 2024 Published 2024-03-14.

What to do now

Contact JENI PANDYA at 514‐905‐2012 (JENI.PANDYA@ICUMED.COM) and SHUI YEE KUAN at 514‐905‐2645

Recall number

75242

Official notice

2024-03-14

Watch this recall in the app

The hazard

Smiths Medical is issuing this letter to notify customers not to use Cardinal Health branded Monoject syringes with Medfusion 3500 and 4000 Syringe Pumps. On September 20, 2023, Cardinal Health issued a medical device product correction for the Cardinal Health branded Monoject Luer-Lock Tip Syringes due to demonstrated recognition and compatibility issues with syringe infusion pumps due to changes made to the dimensions of the syringes. As a result, Cardinal Health recommends that these syringes not be used on syringe infusion pumps. Recall Start Date: February 29, 2024

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

75242

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Affected products

Product 1

Affected products - Medfusion Syringe Infusion Pumps, Lot or serial number - Not applicable., Model or catalog number - 3500G 3500SD-500 3500VX-500 3500-402 3500E 3500VX-415 3500 3500-415 3500VX-414 3500-306 3500-414 3500-500 3500SD 3500VX 3500ZE 3500BC 3500VX-306

Product 2

Affected products - Medfusion Model 4000 Syringe Infusion Pump, Lot or serial number - Not applicable., Model or catalog number - 4000-0101-249 4000-0101-50 4000-0105-51 4000-0105-249 4000-0105-78 4000-0106-00 4000-0106-01 4000-0101-78 4000-0100-50 4000-0106-231 4000-0101-51 4000-0105-50

Risk / hazard

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

Brand

Smiths Medical Asd, Medfusion Syringe Infusion Pumps

Manufacturer

Not provided

Phone

Not provided

Brand: Smiths Medical Asd, Medfusion Syringe Infusion Pumps.

Source & status

Source

Health Canada

Tier

official

Recall details

Recall number

75242

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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