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Adult manual resuscitator

Official notice

16 May 2025

CriticalHealth Canada

An official Health Canada notice concerns Adult manual resuscitator. Medline was informed by its contract manufacturer that the Adult Manual Resuscitator with mask, bag reservoir, and filter, CPRM1116F, was misassembled. Instead of the filter pre-attached at the exhalation port, it was connected to the patient port where the mask attaches. If the filter is incorrectly attached and not noticed before patient use, there could be a potential delay in patient resuscitation, which may result in life-threatening consequences, including hypoxia, hypercapnia, organ failure or death. Recall Start Date: May 9, 2025 Published 2025-05-16.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77464

Official notice

2025-05-16

The hazard

Medline was informed by its contract manufacturer that the Adult Manual Resuscitator with mask, bag reservoir, and filter, CPRM1116F, was misassembled. Instead of the filter pre-attached at the exhalation port, it was connected to the patient port where the mask attaches. If the filter is incorrectly attached and not noticed before patient use, there could be a potential delay in patient resuscitation, which may result in life-threatening consequences, including hypoxia, hypercapnia, organ failure or death. Recall Start Date: May 9, 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.

Recall Numbers

77464

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Affected products

Product 1

Affected products - Adult Manual Resuscitator, Lot or serial number - 526796 526804 526797 526805 526817 526782 526802 526815 526807 526811 526800 526806 526809 526814 526816 526798 526808 526790 526810 526818, Model or catalog number - CPRM1116F

Risk / hazard

Medline was informed by its contract manufacturer that the Adult Manual Resuscitator with mask, bag reservoir, and filter, CPRM1116F, was misassembled. Instead of the filter pre-attached at the exhalation port, it was connected to the patient port where the mask attaches. If the filter is incorrectly attached and not noticed before patient use, there could be a potential delay in patient resuscitation, which may result in life-threatening consequences, including hypoxia, hypercapnia, organ failure or death. Recall Start Date: May 9, 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: Medline Lp, Adult Manual Resuscitator.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

critical

Recall details

Recall number

77464

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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