Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Descrip
FDA device recall Z-1688-2024 · posted 2024-04-24 · Open, Classified
Recall details
- Recalling firm
- Electro Medical Systems SA
- 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).
- Action taken
- On 3/13/2024, the firm notified, via email, its distributors and asked them to extend the recall to end users. Currently the Customer Notification Letter to end users is being drafted (date of distribution pending). The Customer Notification Letter will information customers that the firm is recalling WATER, CLEANER and PIEZON Bottles due to a manufacturing issue that may result with these affected bottles to leak and/or break and in unfavorable cases may lead to injuries. Customers are instructed to: 1. Cease use of the affected products. 2. Return the affected products to their distributors For questions or assistance, contact EMS Dallas at 1-800-367-0367 or email to emsrepairs@ems-na.com Monday thru Friday 8:00 a.m. to 5:00 p.m. CST.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- ELC
- Quantity affected
- 54
- 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,
- Date initiated
- 2024-03-13
- Date posted
- 2024-04-24
- Location
- Nyon, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One (K190124) | E.M.S Electro Medical Systems S.A | 2019-10-20 |