Reported May 1, 2024 · Ongoing
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product…
Electro Medical Systems SA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Electro Medical Systems SA · Chemin De La Vuarpilliere 31 · Nyon, N/A · N/A
Is this the product you have?
- Brand NameCLEANER
- BOTTLE Product NameCLEANER
- BOTTLE Model/Catalog NumberEG-1000
- Software VersionN/A
- Product DescriptionCLEANER 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
- ComponentYES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
- Lot codes and dates
- Lot CodeModel
- numberEG-1000
- UDI07613353180225
- Lot number16442-210
- Expiry date2026-04
- AIRFLOW Prophylaxis Master UDI-DI codes07613353213183 and 07613353184148
- AIRFLOW ONE UDI-DI code07613353184124
- Product Serial Numbersx1 OF-99-12848-1
342 of 342 codes
KU23665KU23668KU23669KU23670KU23671KU23673KU23674KU23675KU23676KU23677KU23679KU23680KU23681KU23682KU23683KU23684KU23685KU23687KU23690KU23691KU23692KU23693KU23694KU23695KU23696KU23697KU23698KU23699KU23702KU23704KU23705KU23707KU23708KU23709KU23710KU23711KU23712KU23713KU23714KU23715KU23717KU23718KU23720KU23721KU23723KU23724LD05012LD05033LD05034LD05035LD05036LD05037LD05100LD05101LD05102LD05103LD05104LD05105LD05106LD05107
- Amount recalled
- 342
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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