Reported May 1, 2024 · Ongoing
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 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 NamePIEZON
- Bottle Product NamePIEZON
- Bottle Model/Catalog NumberEG-111
- Software VersionN/A
- Product DescriptionThese bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use
- ComponentYES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published — Lot Code EG-11107613353180249UDI: 07613353180249 — Lot number: 16442-190, Expiry date: 2026-04 EG-11107613353180249UDI: 07613353180249 — 076133532131830761335318414807613353184124Lot number: 16694-30 Expiry date: 2026-07 AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: KU23667 KU23689 KU23700 KU23701 KU23703 KU23722 KU24328 KU24330 KU24331 KU24333 KU24334 KU24335 KU24337 KU24339 KU24340 KU24341 KU23719 KU24336 KU24338 KU24342 KU24344 KU24346 KU24349 KU24354 KU24356 KU23666 KU23672 KU23678 KU23686 KU23688 KU23706 KU23716 KU24343 KU24345 KU24347 KU24348 KU24350 KU24351 KU24353 KU24355 KU24357 KU24363 KU24366 KU24367 KU24368 KU24369 KU24370 KU24371 KU24372 KU24373 KU24359 KU24360 KU24361 KU24365 - Amount recalled
- 54
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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