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Swabsleeve™ and swabcap™

Official notice

15 Jul 2025

MediumHealth Canada

An official Health Canada notice concerns Swabsleeve™ and swabcap™. ICU Medical has identified a lot-specific issue where the seal between the foil lid and the plastic container of the SwabCap™ may be incomplete because of a manufacturing issue. This may result in evaporation of the isopropyl alcohol on the the sponge. Recall start date: May 26, 2025 Published 2025-07-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77562

Official notice

2025-07-15

The hazard

ICU Medical has identified a lot-specific issue where the seal between the foil lid and the plastic container of the SwabCap™ may be incomplete because of a manufacturing issue. This may result in evaporation of the isopropyl alcohol on the the sponge. Recall start date: May 26, 2025

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.

Lots

-specific

Recall Numbers

77562

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Affected products

Product 1

Affected products - SwabSleeve™, Lot or serial number - 14287459, Model or catalog number - SCXT3-5-2000

Product 2

Affected products - SwabCap™, Lot or serial number - 14258208, Model or catalog number - SCXT3-2000

Product 3

Affected products - SwabSleeve™, Lot or serial number - 14321652, Model or catalog number - SCXT3-5-2000

Product 4

Affected products - SwabSleeve™, Lot or serial number - 14258743, Model or catalog number - SCXT3-5-2000

Risk / hazard

ICU Medical has identified a lot-specific issue where the seal between the foil lid and the plastic container of the SwabCap™ may be incomplete because of a manufacturing issue. This may result in evaporation of the isopropyl alcohol on the the sponge. Recall start date: May 26, 2025

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: Icu Medical, Swabsleeve™ And Swabcap™.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77562

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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