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Microclave clear sets

Official notice

8 Aug 2022

MediumHealth Canada

An official Health Canada notice concerns Microclave clear sets. ICU Medical has identified the potential for a manufacturing defect within specific lots of Microclave clear sets, which may result in a visible gap between the Microclave clear connectors top and bottom housings. Inadequate connection between the Microclave clear connectors top and bottom housings may potentially cause fluid leak, blood loss, air ingress, or contamination. Recall start date: July 27, 2022 Published 2022-08-08.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64449

Official notice

2022-08-08

The hazard

ICU Medical has identified the potential for a manufacturing defect within specific lots of Microclave clear sets, which may result in a visible gap between the Microclave clear connectors top and bottom housings. Inadequate connection between the Microclave clear connectors top and bottom housings may potentially cause fluid leak, blood loss, air ingress, or contamination. Recall start date: July 27, 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

64449

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Affected products

Product 1

Affected products - Double Connector, Lot or serial number - 5724498, Model or catalog number - MC100-DC

Product 2

Affected products - Pressure Infusion Ext Set W/Microclave Clear, Clamp, Rotating Luer, Lot or serial number - 5736601 5789780, Model or catalog number - MC33213

Product 3

Affected products - ifuse Microclave Ext Set, Lot or serial number - 5725526 5725559, Model or catalog number - MC33691 MC33636

Product 4

Affected products - Trifuse Microclave Ext Set, Lot or serial number - 5772352 5753321 5754294 5762576 5744883 5664461, Model or catalog number - MC33769 MC33547 MC33687

Product 5

Affected products - Bifuse Ext Set W/2 Microclave Clear, Clamp, Rotating Luer, Lot or serial number - 5772085 5692316 5677797, Model or catalog number - MC330476 K7059-001

Product 6

Affected products - Ext Set W/Remv Microclave Clear, Clamp, Rotating Luer, Lot or serial number - 5772609 5679662 5772630 5772606, Model or catalog number - MC3325

Risk / hazard

ICU Medical has identified the potential for a manufacturing defect within specific lots of Microclave clear sets, which may result in a visible gap between the Microclave clear connectors top and bottom housings. Inadequate connection between the Microclave clear connectors top and bottom housings may potentially cause fluid leak, blood loss, air ingress, or contamination. Recall start date: July 27, 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: Icu Medical, Microclave Clear Sets.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64449

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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