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Class 2 Device Recall WATER BOTTLE |
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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
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Product Classification |
Scaler, ultrasonic - Product Code ELC
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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
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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
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Recalling Firm/ Manufacturer |
Electro Medical Systems SA Chemin De La Vuarpilliere 31 Nyon Switzerland
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For Additional Information Contact |
Alfred Gonzales 972-6908382
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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).
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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
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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.
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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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