| 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 |
|
| 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 |