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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00213-1
Product Name/Description	Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kit Ellex 14.9mm OD - Prager Adult - Prager scleral shell for Biometry Model No: P-106, PRAGERADULT Lot No: AA003725, 15-385, 15-393 and 16-207 Ellex 12.5mm OD - Prager Child - Prager scleral shell for Biometry Model No: P-106SV, PRAGERCHILD Lot No: 15-326 10 MHZ Biometric A Scan Probe Kit (includes Prager Adult) Model No: 10MHZASCAN-KIT Lot No: 15M028, 15L049, 15M046, 15M057 and 16K050 ARTG Number: 242235
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	23/02/2017
Responsible Entity	Ellex Medical Pty Ltd
Reason/Issue	The Prager shell is supplied as an accessory with the Ellex ‘Eyecubed V4' and ‘Eyeone’ Ophthalmic Ultrasound Diagnostic Device. Prager shells are reusable semi critical devices requiring high level disinfection. They are required to be cleaned and disinfected before the first use and between patient uses. An issue has been identified with the manufacturer's Instructions for Use (IFU) for the Prager shell. This IFU does not provide adequate details on the cleaning and disinfection procedures. Validated cleaning and disinfection procedures, which will provide the required level of cleaning and disinfection, have been included in a revised version of the Ellex Prager Shell Care Instructions. To date, there have been no adverse events reported to Ellex for the Prager shells.
Recall Action	Recall for Product Correction
Recall Action Instructions	Ellex is advising customers with affected stock to ensure that cleaning and disinfection procedures of the Prager shell are performed in accordance with the “Ellex Prager Shell Care Instructions” supplied. This action has been closed-out on 22/03/2018.
Contact Information	08 8104 5200 - Ellex Medical