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FDA (Device enforcement)Recalled 2024-03-13class ii

Electro Medical Systems SA: 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 PROPH

Hazard

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).

Details from the source

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, Quantity: 342 Lot/code info: Lot Code: Model number: EG-1000, UDI: 07613353180225, Lot number: 16442-210, Expiry date: 2026-04. AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: KU23665 KU23668 KU23669 KU23670 KU23671 KU23673 KU23674 KU23675 KU23676 KU23677 KU23679 KU23680 KU23681 KU23682 KU23683 KU23684 KU23685 KU23687 KU23690 KU23691 KU23692 KU23693 KU23694 KU23695 KU23696 KU23697 KU23698 KU23699 KU23702 KU23704 KU23705 KU23707 KU23708 KU23709 KU23710 KU23711 KU23712 KU23713 KU23714 KU23715 KU23717 KU23718 KU23720 KU23721 KU23723 KU23724 LD05012 LD05033 LD05034 LD05035 LD05036 LD05037 LD05100 LD05101 LD05102 LD05103 LD05104 LD05105 LD05106 LD05107 LD05108 LD05109 LD05110 LD05111 LD05112 LD05113 LD05114 LD05115 KU23666 KU23667 KU23672 KU23678 KU23686 KU23688 KU23689 KU23700 KU23701 KU23703 KU23706 KU23722 KU24328 KU24341 KU23716 KU23719 KU24342 KU24343 KU24344 KU24345 KU24346 KU24347 KU24348 KU24349 KU24350 KU24351 LD05116 LD05117 LD05118 LD05119 LD05120 LD05121 LD05122 LD05513 LD05514 LD05516 LD05517 LD05518 LD05519 LD05520 LD05521 LD05522 LD05523 LD05524 LD05525 LD05526 LD05527 LD05528 LD05529 LD05530 LD05531 LD05532 LD05533 LD05534 LD05535 KU21778 KU21884 KU21915 KU21948 KU21972 KU22135 KU22136 KU22137 KU22138 KU22139 KU22140 KU22141 KU22142 KU22143 KU22146 KU22147 KU22165 KU22166 KU22167 KU22168 KU22169 KU22170 KU22171 KU22172 KU22173 KU22174 KU22175 KU22176 KU22177 KU22178 LD05038 LD05039 LD05041 LD05042 KU2176

UPC codes

07613353180225, 07613353213183, 07613353184148, 07613353184124

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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