Recall MonitorHealth ProductsType I recall
Adult Manual Resuscitator
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Anaesthesiology
Product: Adult Manual Resuscitator
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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