Health product recall

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

Starting date:
October 20, 2020
Posting date:
November 27, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74413

Last updated:
2020-11-27

Affected Products

LAERDAL COMPACT SUCTION UNIT 4 (LCSU 4)

Reason

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.

Affected products

LAERDAL COMPACT SUCTION UNIT 4 (LCSU 4)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

880051
880052
880061
880062
881151
881152

Companies
Manufacturer

Laerdal Medical AS

Tanke Svilandsgate 30, P.O. Box 377,

Stavanger, Rogaland Fylke

4002

NORWAY