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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-01081-1
Product Name/Description	Sterile Water Syringe supplied with Atrium Express Dry Suction Dry Seal Chest Drain Product Code: 4000-100N Lot numbers: 466951, 467193, 467195, 469918, 469920, 471069, 472581, 474076, 474950, 475228, 475487, 477950, 485229, 485230, 487808, 489877, 490762, 492644, 496207, 496692, 497139, 498578. ARTG 119726 (Getinge Australia Pty Ltd - Drainage system, pleural)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/12/2023
Responsible Entity	Getinge Australia Pty Ltd
Reason/Issue	The Express chest drain was shipped with sterile water from Nurse Assist, which could be used to determine if an active pneumothorax (“air leak”) is present. On November 8, 2023, Getinge received notice from Nurse Assist, LLC that its Sterile Water, USP, 30mL syringes were being recalled because they could not be verified to be sterile. Pre-packaged with every Express chest drain, the 30mL sterile water syringe is intended to fill the air leak monitor chamber for air leak monitor chamber for air leak detection during or after initial device set-up, if desired. Express Chest Drains labelling states that the fluid is sterile. During a chest drain knock-over event (device not kept in upright position), the water in the air leak monitor chamber could migrate from the air leak monitor chamber to the drainage fluid collection chamber. The patient could potentially be exposed to an infectious pathogen; therefore, the potential risk to the patient is high.
Recall Action	Recall
Recall Action Instructions	This action affects the sterile water syringe only (pre-packaged with the Express chest drains). The supplied sterile water syringe must not be used. Users may: 1. If visualisation of active pneumothorax is not needed, keep the affected Express chest drains and set up without water. 2. Use the Express chest drain as intended by replacing the sterile water syringe provided with the drain with a new syringe filled with sterile water using aseptic technique. 3. Return the affected Express chest drains to Getinge Australia via Return Good Authorization (RGA). If users have any affected Express 4000-100N from the affected lots, this product can be returned.
Contact Information	1800 438 464 - Getinge