In a critical safety notice issued by Health Canada, healthcare providers are being warned about a serious recall affecting Adult Manual Resuscitators due to a misassembly issue that could lead to delayed resuscitation and life-threatening outcomes, including hypoxia, hypercapnia, organ failure, and even death.
Table of Contents
Product Overview
Recalled Device:
Adult Manual Resuscitator with mask, bag reservoir, and filter
Manufacturer:
Medline (via contract manufacturer)
Model/Catalog Number:
CPRM1116F
Recall Start Date:
May 9, 2025
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What’s the Problem?
The issue stems from a critical misassembly of the resuscitator components. According to Medline, the filter that should have been pre-attached at the exhalation port was instead connected to the patient port, where the mask is typically attached.
This means that if the device is used without detecting the misplacement, it could cause:
- Obstructed airflow
- Delay in oxygen delivery
- Potential failure to properly ventilate the patient
Such a failure during an emergency could lead to:
- Hypoxia (oxygen deficiency in the body)
- Hypercapnia (excess carbon dioxide)
- Organ damage or failure
- Death, particularly in critical care or emergency resuscitation scenarios
Affected Lot Numbers
The following serial or lot numbers have been identified in the recall:
526796, 526804, 526797, 526805, 526817, 526782, 526802, 526815, 526807, 526811, 526800, 526806, 526809, 526814, 526816, 526798, 526808, 526790, 526810, 526818
Healthcare providers and institutions are advised to immediately inspect their inventory and quarantine any affected units.
What Healthcare Providers Should Do
- Stop using the affected product immediately.
- Check the model number (CPRM1116F) and lot/serial numbers listed above.
- If you find any affected resuscitators:
- Do not use them.
- Contact Medline for further instructions and replacement procedures.
- Report any incidents or adverse health events to Health Canada’s MedEffect system.
Why This Matters
Manual resuscitators are life-saving emergency devices, commonly used in:
- Emergency departments
- ICUs
- EMS and paramedic response
- Surgical recovery units
Any malfunction or delay during resuscitation could mean the difference between life and death, particularly in time-sensitive scenarios involving cardiac arrest, respiratory failure, or trauma.
Final Reminder
If you’re a hospital administrator, paramedic, clinician, or involved in procurement of medical supplies, act immediately to:
- Verify your stock
- Prevent use of affected devices
- Ensure patient safety
Your prompt response could prevent a potentially tragic incident.
Stay updated on medical device recalls and safety notices through Health Canada’s medical device recall database and regular safety alerts.