Recall Z-1687-2024
Electro Medical Systems SA · initiated March 13, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
Codes / lots: Lot Code: Model number: EG-121, UDI: 07613353180287 Lot number: 16457-10, Expiry date: 2026-04 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-80, Expiry date: 2026-04 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-120, Expiry date: 2026-07 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-130, Expiry date: 2026-10 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-140, Expiry date: 2026-10 Model number: EG-121, UDI: 07613353180287 Lot number: 16866-80, Expiry date: 2026-10: batch not impacted by the deviation, but as the expiry date is the same than other batches impacted it was decided to recall this batch as well because the expiry date is engraved on the bottles and the user might not be able to differentiate the batch number if the packaging was disposed of. AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: LD04753 LD04757 LG10166 LG10167 LG10168 LG10169 LG10170 LG10171 LG10172 LG10173 LG10174 LG10175 LG10151 LG10152 LG10153 LG10154 LG10155 LG10156 LG10157 LG10158 LG10159 LG10160 LG10161 LG10162 LG10163 LG10164 LG10165 OF-04-05367-1 LG10413…
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).
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1687-2024
- Initiated
- March 13, 2024
- Posted by FDA
- April 24, 2024
- Product code
- ELC – Scaler, Ultrasonic
- Quantity
- 462
- 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…
- Recalling firm
- Electro Medical Systems SA, Nyon
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1686-2024 Class II | Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000…Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts… | 03/13/2024Open, Classified |
| Z-1688-2024 Class II | Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111…Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts… | 03/13/2024Open, Classified |