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Cardinal health level 3 isolation gowns

Official notice

20 Nov 2024

Last checked

20 Nov 2024

Medium riskHealth Canada

An official Health Canada notice concerns Cardinal health level 3 isolation gowns. The listed product codes and all lots of Cardinal Health Level 3 Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (the Association for the Advancement of Medical Instrumentation) level 3 protection requirements. The raw material identified has demonstrated possible degradation due to exposure to lighting, temperature, and relative humidity beyond the manufacturer recommended limits. This product recall is specific to the codes listed. Other codes are not impacted. Recall Start Date: November 5, 2024 Published 2024-11-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76546

Official notice

2024-11-20

The hazard

The listed product codes and all lots of Cardinal Health Level 3 Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (the Association for the Advancement of Medical Instrumentation) level 3 protection requirements. The raw material identified has demonstrated possible degradation due to exposure to lighting, temperature, and relative humidity beyond the manufacturer recommended limits. This product recall is specific to the codes listed. Other codes are not impacted. Recall Start Date: November 5, 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

76546

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Affected products

Product 1

Affected products - Convertor Isolation Gown, AAMI Level 3 Protection, Lot or serial number - All lots., Model or catalog number - AT6200 AT6100

Risk / hazard

The listed product codes and all lots of Cardinal Health Level 3 Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (the Association for the Advancement of Medical Instrumentation) level 3 protection requirements. The raw material identified has demonstrated possible degradation due to exposure to lighting, temperature, and relative humidity beyond the manufacturer recommended limits. This product recall is specific to the codes listed. Other codes are not impacted. Recall Start Date: November 5, 2024

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: Cardinal Health 200 Also Trading Cardinal Health, Cardinal Health Level 3 Isolation Gowns.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

76546

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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