Product Wiki · Recalls · Health Canada — Marketed Health Products

Archived - Cleaning of Reusable Resuscitators and PEEP Valves — recall 24512

Health Canada — Marketed Health Products · Canada · 2000-09-07

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Agency
Health Canada — Marketed Health Products
Recall identifier
24512
Date of alert
2000-09-07
Country / jurisdiction
Canada
Risk type
recall
Product category
Medical devices
Product type
Marketed health products
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Resuscitators and Positive End Expiratory Pressure (PEEP) valves are likely to become contaminated during use by microorganism and other foreign material, or by patient fluids. Inadequate cleaning may affect the safe operation of the resuscitator. The Medical Devices Bureau of the Health Products and Food Branch has recently investigated two similar incidents from different hospitals involving a reusable resuscitator and a reusable PEEP valve. In both incidents, valves in the exhalation pathway were stuck closed, preventing patient exhalation and causing a step-wise increase in lung inflation and the risk of pneumothorax. The resuscitators were assigned to individual patients and were re-used without cleaning. The observation of a dried substance on the valves in the exhalation pathway suggests that patient fluids and condensate from exhalation deposited on them during use and then dried between use, causing them to stick to the valve seat. Similar cases of sticking valves on resuscitators without PEEP attachments have been reported in the past, and may have been caused by inadequate cleaning of the valve components to eliminate surface residue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/archived-cleaning-reusable-res

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