Product Wiki · Recalls · Health Canada — Medical Devices

LAERDAL COMPACT SUCTION UNIT 4 (LCSU 4) (2020-10-20) — recall 61867

Health Canada — Medical Devices · Canada · 2020-11-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61867
Date of alert
2020-11-27
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The service life of LCSU 4 units manufactured in the period 9 August 2018 to 6 June 2020 may be reduced due to component failures within the internal vacuum air pump. These component failures will result in the LCSU 4 continuing to operate, but not able to provide any suction. As of Sept 25, 2020, Laerdal had received complaints, from less than two percent of all potentially affected LCSU 4s, involving this failure condition. Prolonged use of the LCSU 4 at vacuum levels above 300 mmHg, either during device testing or during patient use, may cause an air pump component to fail resulting in loss of all suction. Alternate suction devices or methods will be required to continue suctioning.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/laerdal-compact-suction-unit-4

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