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U.S. Department of Health and Human Services

Class 2 Device Recall WATER BOTTLE

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  Class 2 Device Recall WATER BOTTLE see related information
Date Initiated by Firm March 13, 2024
Date Posted April 24, 2024
Recall Status1 Open3, Classified
Recall Number Z-1687-2024
Recall Event ID 94293
510(K)Number K190124  
Product Classification Scaler, ultrasonic - Product Code ELC
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
Code Information 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 LG10414 LG10416 LG10418 LG10421 LG11050 LG11051 LG11052 LG11053 LG11054 LG11055 LG11056 LG11057 LG11127 LG11128 LG11129 LG11130 LG11131 LG11132 LG11133 LG11134 LG11135 LG11136 LG11313 LG11314 LG11315 LG11316 LG11317 LG11318 LG11319 LG11320 LG11321 LG11322 LG11323 LG11324 LG11325 LG11326 LG11327 LG11328 LG11329 LD05012 LD05033 LD05034 LD05035 LD05036 LD05037 LD05038 LD05039 LD05041 LD05042 LD04674 LD04913 LD04914 LD04915 LD04916 LD04917 LG10681 LG10682 LG10683 LG10684 LG10685 LG10686 LG10687 LG10690 LG10691 LG10692 LG10693 LG10694 LG10695 LG10696 LG10697 LG10698 LG10699 LG10700 LG10701 LG10702 LG10703 LG10704 LG10705 LG10706 LG10707 LG10908 LG10909 LG10910 LG10911 LG10912 LG10913 LG10914 LG10915 LG10916 LG10917 LG10918 LG10919 LG10920 LG10921 LG10929 LG10930 LG10931 LG10932 LG10933 LG10934 LG10935 LG10936 LG10937 LG10938 LG10939 LD04918 LD04919 LD04920 LD04921 LD04922 LD04923 LD04924 LD04925 LD04926 LD04927 LD04928 LD04930 LD04931 LD04932 LD04933 LD04934 LD04935 LD04936 LD04937 LD04938 LG10987 LG10988 LG10989 LG10990 LG10991 LG10992 LG10993 LG10994 LG10995 LG10996 LG10997 LG10998 LG10999 LG11000 LG11001 LG11002 LG11003 LG11004 LG11006 LG11005 LG11007 LG11008 LG11009 LG11010 LG11011 LG11013 LG11014 LG11015 LG11016 LG11017 LG11018 LG11019 LG11020 LG11021 LG11022 LG11023 LG11024 LG11025 LG11026 LG11027 LG11028 LG11029 LG11030 LG11031 LG11032 LG11033 LG11034 LG11035 LG11036 LG11037 LD05115 LD05120 LD05121 LD05122 LD05105 LD05107 LD05108 LD05110 LD05114 LD05093 LD05094 LD05095 LD05096 LD05097 LD05098 LD05099 LD05100 LD05102 LD05103 LD05104 LD04939 LD04940 LD04941 LD04942 LD05106 LD05111 LD05112 LD05113 LD05116 LD05117 LD05118 LD05119 LG12099 LG12098 LG12097 LG12096 LG12095 LG12094 LG12093 LG12092 LG12091 LG12090 LG12089 LG12088 LG12087 LG12086 LG12085 LG12084 LG12083 LG12082 LG12076 LG12075 LG12075 LG12076 LG12082 LG12083 LG12084 LG12085 LG12086 LG12087 LG12088 LG12089 LG12090 LG12091 LG12092 LG12093 LG12094 LG12095 LG12096 LG12097 LG12098 LG12099 LD05101 LD05109 LD05513 LD05514 LD05516 LD05517 LD05518 LD05519 LD05520 LD05521 LD05522 LD05523 LD05524 LD05525 LD05526 LD05527 LD05528 LD05529 LD05530 LD05531 LD05532 LD05533 LD05534 LD05535 LD05536 LD05537 LD05538 LD05539 LD05540 LD05541 LD05542 LD05101 LD05109 LD05513 LD05514 LD05516 LD05517 LD05518 LD05519 LD05520 LD05521 LD05522 LD05523 LD05524 LD05525 LD05526 LD05527 LD05528 LD05529 LD05530 LD05531 LD05532 LD05533 LD05534 LD05535 LD05536 LD05537 LD05538 LD05539 LD05540 LD05541 LD05542 LD05607 LD05664 LD05665 LD05666 LD05667 LD05668 LD05669 LD05670 LD05671 LD05672 LD05673 LD05674 LD05675 LD05676 LD05677 LD05678 LD05679 LD05680 LD05681 LD05682 LD05683 LD05684 LD05685 LD05686 LD05687 LG13419 LG13420 LG13421 LG13422 LG13423 LG13424 LG13425 LG13426 LG13427 LG13428 LD05723 LD05724 LD05725 LD05726 LD05727 LG13975 LG13976 OF-04-05473-1 LG11370 LG11369 LG11368 LG11367 LG11366 LG11365 LG11364 LG11363 LG11362 LG11361 LG11360 LG11359 LG11358 LG11357 LG11356 LG11352 LG11351 LG11350 LG11349 LG11348 LG11347 LG11346 LG11345 LG11344 LG11343 LG11342 LG11341 LG11340 LG11339 LG11338 LG11337 LG11336 LG11335 LG11329 LG11328 LG11327 LG11326 LG11325 LG11324 LG11323 LG11322 LG11321 LG11320 LG11319 LG11318 LG11317 LG11316 LG11315 LG11314 LG11313 LD05092 LD05091 LD05090 LD05089 LD05088 LD05087 LD05086 LD05085 LD05084 LD05083 LD05082 LD05081 LD05080 LD05079 LD05078 LD05077 LD05076 LD05075 LD05074 LD05073 LD05072 LD05071 LD05070 LD05069 LD05068 LD05067 LD05066 LD05065 LD05064 LD05063 LD04929
Recalling Firm/
Manufacturer		 Electro Medical Systems SA
Chemin De La Vuarpilliere 31
Nyon Switzerland
For Additional Information Contact Alfred Gonzales
972-6908382
Manufacturer 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 2		 Process control
Action 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.
Quantity in Commerce 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 OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = ELC and Original Applicant = E.M.S Electro Medical Systems S.A.
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