No image published for this recall

No image published for this recall

Cadd administration set

Official notice

21 Dec 2022

Last checked

21 Dec 2022

Medium riskHealth Canada

An official Health Canada notice concerns Cadd administration set. Manufacturing variations may cause the green cadd flow stop arm to compress and partially occlude the tubing before clinical use. If this occurs, there is a potential that the occlusion does not resolve when an affected reservoir or administration set is connected to the pump, and the pump may not detect the occlusion. This may result in underdelivery, despite the pump displaying that the infusion is running properly. Cadd flow stop medication cassette reservoirs and cadd flow stop administration sets provide free-flow protection. By design, a green, spring-loaded pivoting arm automatically squeezes the tubing closed when the reservoir or administration set is not installed on a pump. Connecting the reservoir or administration set to the pump causes the pump to push the flow stop arm, enabling fluid flow through the tubing. In certain circumstances, the tubing may remain occluded even though the cadd reservoir or administration set is loaded into the pump. Recall start date: November 29, 2022 Published 2022-12-21.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72397

Official notice

2022-12-21

The hazard

Manufacturing variations may cause the green cadd flow stop arm to compress and partially occlude the tubing before clinical use. If this occurs, there is a potential that the occlusion does not resolve when an affected reservoir or administration set is connected to the pump, and the pump may not detect the occlusion. This may result in underdelivery, despite the pump displaying that the infusion is running properly. Cadd flow stop medication cassette reservoirs and cadd flow stop administration sets provide free-flow protection. By design, a green, spring-loaded pivoting arm automatically squeezes the tubing closed when the reservoir or administration set is not installed on a pump. Connecting the reservoir or administration set to the pump causes the pump to push the flow stop arm, enabling fluid flow through the tubing. In certain circumstances, the tubing may remain occluded even though the cadd reservoir or administration set is loaded into the pump. Recall start date: November 29, 2022

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

72397

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Affected products

Product 1

Affected products - Medication Cassett Reservior, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 21-7308-24 21-7301-24 21-7309-24 21-7300-24 21-7310-24 21-7302-24

Product 2

Affected products - Cadd Yellow Administration Set With Nrfit Connectors, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 21-7624-24 21-7649-24

Product 3

Affected products - Cadd Administration Set, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 21-7321-24 21-7324-24 21-7349-24 21-7395-24 21-7339-24 21-7343-24 21-7391-24 21-7333-24 21-7394-24 21-7346-24 21-7323-24 21-7336-24 21-7363-24 21-7383-24 21-7390-24 21-7322-24 21-7359-24

Risk / hazard

Manufacturing variations may cause the green cadd flow stop arm to compress and partially occlude the tubing before clinical use. If this occurs, there is a potential that the occlusion does not resolve when an affected reservoir or administration set is connected to the pump, and the pump may not detect the occlusion. This may result in underdelivery, despite the pump displaying that the infusion is running properly. Cadd flow stop medication cassette reservoirs and cadd flow stop administration sets provide free-flow protection. By design, a green, spring-loaded pivoting arm automatically squeezes the tubing closed when the reservoir or administration set is not installed on a pump. Connecting the reservoir or administration set to the pump causes the pump to push the flow stop arm, enabling fluid flow through the tubing. In certain circumstances, the tubing may remain occluded even though the cadd reservoir or administration set is loaded into the pump. Recall start date: November 29, 2022

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, Cadd Administration Set.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

72397

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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