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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00973-1
Product Name/Description Multiple Laerdal Suction Units (LSU) with NiMH Battery

LSU with Resuable Canister
Product Code: 78000003

LSU with Abbot Receptal canister
Product Code: 78001003

LSU with Bemis Canister
Product Code: 78002001

LSU with Serres Suction Bag Canister System
Product Code: 78003003

All Serial Numbers

ARTG Number: 129688
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 29/07/2016
Responsible Entity Laerdal Pty Ltd
Reason/Issue Laerdal Medical has become aware of a problem related to the use of the Laerdal Suction Unit (LSU) when used with the LSU NiMH battery that has been stored or installed at low temperatures for a prolonged period. The problem may occur if the LSU with a NiMH battery, or the NiMH battery itself, when the core temperature of the battery is low, typically between 0°C and 9°C. If used with a NiMH battery with low core temperature, the LSU may shut off after some seconds when operated at 350 mmHg or 500+ mmHg (46.6 kPa or 66.5+ kPa) settings. If NiMH battery has been stored at temperatures above 9 °C, and used at low temperatures, use should not be affected.
Recall Action Recall for Product Correction
Recall Action Instructions Laerdal is providing users with the optimised vacuum settings depending on the battery core temperature. Users are advised to install or store the batteries in locations where temperatures are above 9°C.

This action has been closed out on 08/11/2018
Contact Information 1800 331 565 - Laerdal Australia