Health product recall

Adult Manual Resuscitator

Last updated

Summary

Product
Adult Manual Resuscitator
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Adult Manual Resuscitator

526796
526804
526797
526805
526817
526782
526802
526815
526807
526811
526800
526806
526809
526814
526816
526798
526808
526790
526810
526818

CPRM1116F

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Medline Industries, Lp

Three Lakes Drive, Northfield, Illinois, United States, 60093

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-77464

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