FDA recall Z-1686-2024

Electro Medical Systems SA · Class II · device

Product

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

Reason for recall

Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Distribution

Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM.

Key facts

Status
Ongoing
Initiation date
2024-03-13
Report date
2024-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Nyon, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1686-2024